valacyclovir Oral Tablet

Brand(s)
Valtrex
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Glaxosmithkline Llc (2013-12-03)
Oldest Current Product
1995-08-01
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\VALACYCLOVIR
FDAOB
ORAL\TABLET\VALACYCLOVIR HYDROCHLORIDE
SPL Active
ORAL\TABLET, COATED\VALACYCLOVIR HYDROCHLORIDE
ORAL\TABLET, FILM COATED\VALACYCLOVIR
ORAL\TABLET, FILM COATED\VALACYCLOVIR HYDROCHLORIDE
ORAL\TABLET\VALACYCLOVIR HYDROCHLORIDE
SPL Moiety
ORAL\TABLET, COATED\VALACYCLOVIR
ORAL\TABLET, FILM COATED\ACYCLOVIR
ORAL\TABLET, FILM COATED\VALACYCLOVIR
ORAL\TABLET\ACYCLOVIR

product(s) by strength(s)

valacyclovir 1000 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001730565ValtrexNDAGlaxosmithkline Llc2002-08-12VALACYCLOVIR HYDROCHLORIDEORALTABLET, FILM COATEDNDA020487f8e0d8f8-cb73-4206-a484-88f5c4fbd719

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540115ANDARoxane Laboratories, Inc2010-05-24VALACYCLOVIR HYDROCHLORIDEORALTABLETANDA078656e228913a-8f12-4a4f-bc14-ba44d6e9ece9
2000937259ANDATeva Pharmaceuticals Usa Inc2010-05-24VALACYCLOVIR HYDROCHLORIDEORALTABLET, FILM COATEDANDA0776553172560a-e692-41f0-9ac3-bf6bfb90c4d6
3003784276ANDAMylan Pharmaceuticals Inc.2010-05-24VALACYCLOVIR HYDROCHLORIDEORALTABLET, FILM COATEDANDA07851856bf715d-8280-4557-9f98-9693932199e5
4005913249ANDAWatson Laboratories, Inc.2010-05-24VALACYCLOVIR HYDROCHLORIDEORALTABLET, FILM COATEDANDA0771353fc60483-3dd9-4d52-a0eb-fceba330e019
5007815209ANDASandoz Inc2010-05-24VALACYCLOVIR HYDROCHLORIDEORALTABLETANDA077478823e203e-acc2-4d75-ae42-f33ca2a1bcd1
6167140697ANDANorthstar Rx Llc2010-05-24VALACYCLOVIR HYDROCHLORIDEORALTABLET, FILM COATEDANDA0906824acf51de-26f7-42b2-8acc-61b800627ef3
7317220705ANDACamber Pharmaceuticals, Inc.2015-05-25VALACYCLOVIR HYDROCHLORIDEORALTABLET, FILM COATEDANDA2030477f5e96e0-534c-47a5-bb79-926088afc73c
8459630559ANDAActavis Inc.2011-04-25VALACYCLOVIR HYDROCHLORIDEORALTABLET, FILM COATEDANDA0903709d6b1146-e7c6-40d5-abe5-46321f4b9b1a
9516600905ANDAOhm Laboratories Inc.2009-11-25VALACYCLOVIR HYDROCHLORIDEORALTABLETANDA07658851f93a1c-90d0-4cbc-90f7-6f1415efd673
10523430052ANDALucid Pharma Llc2010-05-24VALACYCLOVIR HYDROCHLORIDEORALTABLET, FILM COATEDANDA0906821cd5d77f-6478-4176-b703-6bfb3f5cb305
11551110553ANDADr. Reddy'S Laboratories Ltd2010-12-06VALACYCLOVIRORALTABLET, FILM COATEDANDA0790122d38cbdb-4e4d-4174-461d-7a3b6475e6a5
12572370043ANDACitron Pharma Llc2010-05-24VALACYCLOVIR HYDROCHLORIDEORALTABLET, FILM COATEDANDA0906828d1645c0-fd03-4992-9372-98026a26b3af
13597460325ANDAJubilant Cadista Pharmaceuticals, Inc.2012-04-05VALACYCLOVIR HYDROCHLORIDEORALTABLET, FILM COATEDANDA2015063277c17e-f953-2b0a-fe0a-4f5d1aeace9d
14633040905ANDARnabaxy Pharmaceuticals Inc.2007-01-31VALACYCLOVIR HYDROCHLORIDEORALTABLET, FILM COATEDANDA07658826634bf1-c6d8-4d48-9a4e-845c47df07f8
15658620449ANDAAurobindo Pharma Limited2010-05-24VALACYCLOVIR HYDROCHLORIDEORALTABLET, FILM COATEDANDA090682f5cfb61e-d971-4a9c-b9ef-4f3368fe02f5

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formequivalent productapplicationspl
1105440937ANDABlenheim Pharmacal, Inc.2012-04-05VALACYCLOVIR HYDROCHLORIDEORALTABLET, FILM COATED597460325ANDA2015061ea0a3ac-8876-48c1-e054-00144ff8d46c
2216950965ANDARebel Distributors Corp2010-06-11VALACYCLOVIR HYDROCHLORIDEORALTABLET, FILM COATED005913249ANDA07713511d1e166-9577-47b0-a338-d11ab3ba44aa
3430630534Pd-Rx Pharmaceuticals, Inc.VALACYCLOVIR HYDROCHLORIDEORALTABLET, FILM COATED459630559cf0ca407-3a63-4741-ba63-8f164f797b79
4493490886ANDARemedyrepack Inc.2013-04-09VALACYCLOVIR HYDROCHLORIDEORALTABLET, FILM COATED459630559ANDA090370cbd9d853-d138-4bfa-b5b8-5f5b9699dc77
5502680789ANDAAvpak2014-09-22VALACYCLOVIR HYDROCHLORIDEORALTABLET, FILM COATED658620449ANDA0906827f5fc62f-d043-db36-ce92-7adc4f7a79a5
6521250617ANDARemedyrepack Inc.2013-05-29, 2013-12-04VALACYCLOVIR HYDROCHLORIDEORALTABLET, FILM COATED459630559ANDA090370bcea5540-f9cf-489c-9039-2b15d127e412, cd8629b9-a51a-49a1-8521-274f75897a71
7529590303ANDAH.J. Harkins Company, Inc.2010-05-24VALACYCLOVIR HYDROCHLORIDEORALTABLET, FILM COATED005913249ANDA077135bcfc31a1-b604-4cd1-a9e0-681e60d4cd2e
8548683993ValtrexNDAPhysicians Total Care, Inc.2003-04-25VALACYCLOVIR HYDROCHLORIDEORALTABLET, FILM COATED001730565NDA020487b4450539-78ec-4e8a-8cfc-56dcde7984a0
9548686089ANDAPhysicians Total Care, Inc.2010-06-11VALACYCLOVIR HYDROCHLORIDEORALTABLET, FILM COATED005913249ANDA077135b28980df-064b-4fd4-8bf3-1589987671ab
10557000045ANDALake Erie Medical Dba Quality Care Products Llc2010-05-24VALACYCLOVIR HYDROCHLORIDEORALTABLET, FILM COATED658620449ANDA090682d94db477-23c6-418a-9226-125c8552a947
11581185209ANDAClinical Solutions Wholesale2010-05-24VALACYCLOVIR HYDROCHLORIDEORALTABLET007815209ANDA07747833b4df8e-e596-42bc-a116-b36f66a59901
12617860297ANDARemedyrepack Inc.2015-05-20VALACYCLOVIR HYDROCHLORIDEORALTABLET690970154ANDA077135bde79448-2feb-4f61-b390-5ef9fb142995
13631870538ANDAProficient Rx Lp2012-04-05VALACYCLOVIR HYDROCHLORIDEORALTABLET, FILM COATED597460325ANDA201506efe37bd1-a236-43cc-828c-b57e8a704d67
14636293982ValtrexNDABryant Ranch Prepack2002-08-12VALACYCLOVIR HYDROCHLORIDEORALTABLET, FILM COATED001730565NDA020487484affc2-a8fe-4430-bb52-00ad678ca8f1
15636294837ANDABryant Ranch Prepack2007-01-31VALACYCLOVIR HYDROCHLORIDEORALTABLET, FILM COATED633040905ANDA0765884586efe3-82ab-4f2b-b591-606ee7a4219a
16637390552ANDAMckesson Packaging Services A Business Unit Of Mckesson Corporation2012-02-24VALACYCLOVIR HYDROCHLORIDEORALTABLET, FILM COATED167140697ANDA0906821ad90fbf-1fae-4f3f-9aea-6a28420e9f10
17661160482ANDAMedvantx, Inc.2010-05-24VALACYCLOVIR HYDROCHLORIDEORALTABLET, FILM COATED167140697ANDA090682d7aa2791-95d9-4732-afe4-89d70f01d152
18661160516ANDAMedvantx, Inc.2010-05-24VALACYCLOVIR HYDROCHLORIDEORALTABLET, FILM COATED000937259ANDA0776555a0e55c9-950b-4d23-b125-e6ffd42b518f
19680840309ANDAAmerican Health Packaging2014-02-28VALACYCLOVIR HYDROCHLORIDEORALTABLET, FILM COATED658620449ANDA09068223fb4162-2310-486c-ba9f-f7c94b793e56
20680840634ANDAAmerican Health Packaging2012-11-292015-11-11VALACYCLOVIR HYDROCHLORIDEORALTABLET, FILM COATED646790153ANDA090216f08bac58-5633-4e79-9524-838260e4a0b8
21687889554ANDAPreferred Pharmaceuticals, Inc.2013-10-03VALACYCLOVIR HYDROCHLORIDEORALTABLET, FILM COATED646790153ANDA090216c5d2d5e0-4a7c-4d54-b155-c34076302854
22687889984ANDAPreferred Pharmaceuticals, Inc.2015-05-04VALACYCLOVIR HYDROCHLORIDEORALTABLET, FILM COATED597460325ANDA201506fc20acce-c989-42d3-8508-3230a9c8f9a5

valacyclovir 500 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001730933ValtrexNDAGlaxosmithkline Llc1995-08-01VALACYCLOVIR HYDROCHLORIDEORALTABLET, FILM COATEDNDA020487f8e0d8f8-cb73-4206-a484-88f5c4fbd719

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540114ANDARoxane Laboratories, Inc2010-05-24VALACYCLOVIR HYDROCHLORIDEORALTABLETANDA078656e228913a-8f12-4a4f-bc14-ba44d6e9ece9
2000937258ANDATeva Pharmaceuticals Usa Inc2010-05-24VALACYCLOVIR HYDROCHLORIDEORALTABLET, FILM COATEDANDA0776553172560a-e692-41f0-9ac3-bf6bfb90c4d6
3003784275ANDAMylan Pharmaceuticals Inc.2010-05-24VALACYCLOVIR HYDROCHLORIDEORALTABLET, FILM COATEDANDA07851856bf715d-8280-4557-9f98-9693932199e5
4005913248ANDAWatson Laboratories, Inc.2010-05-24VALACYCLOVIR HYDROCHLORIDEORALTABLET, FILM COATEDANDA0771353fc60483-3dd9-4d52-a0eb-fceba330e019
5007815208ANDASandoz Inc2010-05-24VALACYCLOVIR HYDROCHLORIDEORALTABLETANDA077478823e203e-acc2-4d75-ae42-f33ca2a1bcd1
6167140698ANDANorthstar Rx Llc2010-05-24VALACYCLOVIR HYDROCHLORIDEORALTABLET, FILM COATEDANDA0906824acf51de-26f7-42b2-8acc-61b800627ef3
7317220704ANDACamber Pharmaceuticals, Inc.2015-05-25VALACYCLOVIR HYDROCHLORIDEORALTABLET, FILM COATEDANDA2030477f5e96e0-534c-47a5-bb79-926088afc73c
8459630558ANDAActavis Inc.2011-04-25VALACYCLOVIR HYDROCHLORIDEORALTABLET, FILM COATEDANDA0903709d6b1146-e7c6-40d5-abe5-46321f4b9b1a
9516600904ANDAOhm Laboratories Inc.2009-11-25VALACYCLOVIR HYDROCHLORIDEORALTABLETANDA07658851f93a1c-90d0-4cbc-90f7-6f1415efd673
10523430051ANDALucid Pharma Llc2010-05-24VALACYCLOVIR HYDROCHLORIDEORALTABLET, FILM COATEDANDA0906821cd5d77f-6478-4176-b703-6bfb3f5cb305
11551110552ANDADr. Reddy'S Laboratories Ltd2010-12-06VALACYCLOVIRORALTABLET, FILM COATEDANDA0790122d38cbdb-4e4d-4174-461d-7a3b6475e6a5
12556480152ANDAWockhardt Limited2010-05-24VALACYCLOVIR HYDROCHLORIDEORALTABLET, FILM COATEDANDA090216a9e1d18e-ad45-4183-bd98-53c7e0b36556
13572370042ANDACitron Pharma Llc2010-05-24VALACYCLOVIR HYDROCHLORIDEORALTABLET, FILM COATEDANDA0906828d1645c0-fd03-4992-9372-98026a26b3af
14597460324ANDAJubilant Cadista Pharmaceuticals, Inc.2012-04-05VALACYCLOVIR HYDROCHLORIDEORALTABLET, FILM COATEDANDA2015063277c17e-f953-2b0a-fe0a-4f5d1aeace9d
15633040904ANDARnabaxy Pharmaceuticals Inc.2007-01-31VALACYCLOVIR HYDROCHLORIDEORALTABLET, FILM COATEDANDA07658826634bf1-c6d8-4d48-9a4e-845c47df07f8
16646790152ANDAWockhardt Usa Llc.2010-05-24VALACYCLOVIR HYDROCHLORIDEORALTABLET, FILM COATEDANDA090216b6b16acc-608a-418a-bf53-f0e44d7f123a
17658620448ANDAAurobindo Pharma Limited2010-05-24VALACYCLOVIR HYDROCHLORIDEORALTABLET, FILM COATEDANDA090682f5cfb61e-d971-4a9c-b9ef-4f3368fe02f5
18690970153ANDACipla Usa Inc.2010-05-24VALACYCLOVIR HYDROCHLORIDEORALTABLETANDA077135fa2f4056-3503-419d-a1eb-0f2474a61948

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950832ANDARebel Distributors Corp2009-12-03VALACYCLOVIR HYDROCHLORIDEORALTABLET, FILM COATED005913248ANDA0771356b2db776-4f30-4a17-a250-79654b86eca0
2430630200ANDAPd-Rx Pharmaceuticals, Inc.2007-01-31VALACYCLOVIR HYDROCHLORIDEORALTABLET, FILM COATED633040904ANDA076588c89fdb3a-99cb-4e47-88bb-782f5e402f15
3430630498Pd-Rx Pharmaceuticals, Inc.VALACYCLOVIR HYDROCHLORIDEORALTABLET, FILM COATED45963055808cc1cdc-b60f-4991-a600-eba70b6f5e72
4433530883ANDAAphena Pharma Solutions - Tennessee, Llc2010-05-24VALACYCLOVIR HYDROCHLORIDEORALTABLET, FILM COATED523430051ANDA0906822e8d0add-fa4d-4ec1-80d7-29615c76006c
5499990486ValtrexNDALake Erie Medical Dba Quality Care Products Llc2012-03-20VALACYCLOVIR HYDROCHLORIDEORALTABLET, FILM COATED001730933NDA02048721a09954-398a-4514-93c3-7bce55384fa5
6502680788ANDAAvpak2014-09-22VALACYCLOVIR HYDROCHLORIDEORALTABLET, FILM COATED658620448ANDA0906827f5fc62f-d043-db36-ce92-7adc4f7a79a5
7510790093ANDAMylan Institutional Inc.2011-03-07VALACYCLOVIR HYDROCHLORIDEORALTABLET, FILM COATED003784275ANDA0785182f0ecd75-e4b4-4493-b7a4-1666fc555c70
8516550955ANDANorthwind Pharmaceuticals, Llc2014-05-06VALACYCLOVIR HYDROCHLORIDEORALTABLET, FILM COATED459630558ANDA090370ea5f09e7-8060-4ce4-89fb-aaf2fa0e21e1
9532170054ANDAAidarex Pharmaceuticals Llc2010-05-24VALACYCLOVIR HYDROCHLORIDEORALTABLET, FILM COATED646790152ANDA0902160772c392-be52-4d1b-825e-ee321ce9f9cf
10538080635ANDAState Of Florida Doh Central Pharmacy2013-01-01VALACYCLOVIR HYDROCHLORIDEORALTABLET, FILM COATED000937258ANDA077655bdd38bb5-ff30-4392-a151-5234b9342304
11548683804ValtrexNDAPhysicians Total Care, Inc.1996-07-082010-06-30VALACYCLOVIR HYDROCHLORIDEORALTABLET, FILM COATED001730933NDA020487b4450539-78ec-4e8a-8cfc-56dcde7984a0
12548686090ANDAPhysicians Total Care, Inc.2009-12-03VALACYCLOVIR HYDROCHLORIDEORALTABLET, FILM COATED005913248ANDA077135b28980df-064b-4fd4-8bf3-1589987671ab
13551541114ValtrexNDACardinal Health1995-08-01VALACYCLOVIR HYDROCHLORIDEORALTABLET, FILM COATED001730933NDA02048761ea67c2-8c0e-486f-8c0c-6167a1d3d95a
14551544789ANDACardinal Health2012-11-29VALACYCLOVIR HYDROCHLORIDEORALTABLET, FILM COATED680840633ANDA090216b4737737-3767-429e-807d-1c2420f3781d
15551545384ANDACardinal Health2012-09-25VALACYCLOVIR HYDROCHLORIDEORALTABLET, FILM COATED510790093ANDA0785182ff6f83c-9794-47dc-b9ea-1d03c02ff812
16551546837ANDACardinal Health2011-05-23VALACYCLOVIR HYDROCHLORIDEORALTABLET, FILM COATED637390525ANDA090682c7db0cf5-10f0-46e6-98a8-8d8c6cde4227
17552890926ValtrexNDAPd-Rx Pharmaceuticals, Inc.1995-08-01VALACYCLOVIR HYDROCHLORIDEORALTABLET, FILM COATED001730933NDA020487d8028584-4186-41d6-b74b-2535971aa216
18619190066ANDADirect Rx2015-01-01VALACYCLOVIR HYDROCHLORIDEORALTABLET597460324ANDA201506cbd7bb49-7a9c-4383-a158-bfc307db0130
19631870311ANDAProficient Rx Lp2011-04-25VALACYCLOVIR HYDROCHLORIDEORALTABLET, FILM COATED459630558ANDA090370d8242d35-ee3a-4008-81a0-70cdd84a1e7c
20636293610ValtrexNDABryant Ranch Prepack1995-08-01VALACYCLOVIR HYDROCHLORIDEORALTABLET, FILM COATED001730933NDA0204871cc78a3b-6d16-4354-8601-bc10d2b34d02
21636294468ANDABryant Ranch Prepack2010-05-24VALACYCLOVIR HYDROCHLORIDEORALTABLET, FILM COATED005913248ANDA0771351aa34beb-b06b-410c-b483-ba0bd903944a
22637390525ANDAMckesson Packaging Services A Business Unit Of Mckesson Corporation2011-05-23VALACYCLOVIR HYDROCHLORIDEORALTABLET, FILM COATED167140698ANDA0906821ad90fbf-1fae-4f3f-9aea-6a28420e9f10
23680840215ANDAAmerican Health Packaging2014-02-28VALACYCLOVIR HYDROCHLORIDEORALTABLET, FILM COATED658620448ANDA09068223fb4162-2310-486c-ba9f-f7c94b793e56
24680840633ANDAAmerican Health Packaging2012-11-29VALACYCLOVIR HYDROCHLORIDEORALTABLET, FILM COATED646790152ANDA090216f08bac58-5633-4e79-9524-838260e4a0b8
25687889432ANDAPreferred Pharmaceuticals, Inc.2014-09-12VALACYCLOVIR HYDROCHLORIDEORALTABLET007815208ANDA07747867d48963-f7bb-438c-9ad6-45f753e3422f
26759210208ANDALife Line Home Care Services, Inc.2010-05-24VALACYCLOVIR HYDROCHLORIDEORALTABLET, COATED007815208ANDA077478b0e6fa63-7b34-4453-a259-34ffd917f4d7

application(s)

#idtitleapplicantapprovedpatentapproved drug
1ANDA076588VALACYCLOVIR HYDROCHLORIDESUN PHARMACEUTICAL INDUSTRIES LTD2007-01-31ANDA076588_001, ANDA076588_002
2ANDA077135VALACYCLOVIR HYDROCHLORIDECIPLA LTD2010-05-24ANDA077135_001, ANDA077135_002
3ANDA077478VALACYCLOVIR HYDROCHLORIDESANDOZ INC2010-05-24ANDA077478_001, ANDA077478_002
4ANDA077655VALACYCLOVIR HYDROCHLORIDETEVA PHARMACEUTICALS USA2010-05-24ANDA077655_001, ANDA077655_002
5ANDA078070VALACYCLOVIR HYDROCHLORIDEMYLAN PHARMACEUTICALS INC2010-05-24ANDA078070_001, ANDA078070_002
6ANDA078518VALACYCLOVIR HYDROCHLORIDEMYLAN PHARMACEUTICALS INC2010-05-24ANDA078518_001, ANDA078518_002
7ANDA078656VALACYCLOVIR HYDROCHLORIDEROXANE LABORATORIES INC2010-05-24ANDA078656_001, ANDA078656_002
8ANDA079012VALACYCLOVIR HYDROCHLORIDEDR REDDYS LABORATORIES LTD2010-05-24ANDA079012_001, ANDA079012_002
9ANDA090216VALACYCLOVIR HYDROCHLORIDEWOCKHARDT LTD2010-05-24ANDA090216_001, ANDA090216_002
10ANDA090370VALACYCLOVIR HYDROCHLORIDEWATSON LABORATORIES INC2011-03-16ANDA090370_001, ANDA090370_002
11ANDA090500VALACYCLOVIR HYDROCHLORIDEAPOTEX INC2014-04-04ANDA090500_001, ANDA090500_002
12ANDA090682VALACYCLOVIR HYDROCHLORIDEAUROBINDO PHARMA LTD2010-05-24ANDA090682_001, ANDA090682_002
13ANDA201506VALACYCLOVIR HYDROCHLORIDEJUBILANT GENERICS LTD2012-04-03ANDA201506_001, ANDA201506_002
14ANDA203047VALACYCLOVIR HYDROCHLORIDEHETERO LABS LTD UNIT V2015-04-08ANDA203047_001, ANDA203047_002
15NDA020487VALTREXGLAXOSMITHKLINE1995-06-23p6107302, TREATMENT OF HERPES ZOSTER/ TREATMENT OF COLD SORES IN PEDIATRIC PATIENTS TWELVE YEARS OF AGE AND OLDER
p5879706, TREATMENT OF HERPES ZOSTER/ TREATMENT OF COLD SORES IN PEDIATRIC PATIENTS TWELVE YEARS OF AGE AND OLDER, SUBSTANCE
NDA020487_001, NDA020487_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA076588_001RXVALACYCLOVIR HYDROCHLORIDE (EQ 500MG BASE)ORALTABLETFalseAB2007-01-31VALACYCLOVIR HYDROCHLORIDE
2ANDA076588_002RXVALACYCLOVIR HYDROCHLORIDE (EQ 1GM BASE)ORALTABLETFalseAB2007-01-31VALACYCLOVIR HYDROCHLORIDE
3ANDA077135_001RXVALACYCLOVIR HYDROCHLORIDE (EQ 500MG BASE)ORALTABLETFalseAB2010-05-24VALACYCLOVIR HYDROCHLORIDE
4ANDA077135_002RXVALACYCLOVIR HYDROCHLORIDE (EQ 1GM BASE)ORALTABLETFalseAB2010-05-24VALACYCLOVIR HYDROCHLORIDE
5ANDA077478_001RXVALACYCLOVIR HYDROCHLORIDE (EQ 500MG BASE)ORALTABLETFalseAB2010-05-24VALACYCLOVIR HYDROCHLORIDE
6ANDA077478_002RXVALACYCLOVIR HYDROCHLORIDE (EQ 1GM BASE)ORALTABLETFalseAB2010-05-24VALACYCLOVIR HYDROCHLORIDE
7ANDA077655_001RXVALACYCLOVIR HYDROCHLORIDE (EQ 500MG BASE)ORALTABLETFalseAB2010-05-24VALACYCLOVIR HYDROCHLORIDE
8ANDA077655_002RXVALACYCLOVIR HYDROCHLORIDE (EQ 1GM BASE)ORALTABLETFalseAB2010-05-24VALACYCLOVIR HYDROCHLORIDE
9ANDA078070_001RXVALACYCLOVIR HYDROCHLORIDE (EQ 500MG BASE)ORALTABLETFalseAB2010-05-24VALACYCLOVIR HYDROCHLORIDE
10ANDA078070_002RXVALACYCLOVIR HYDROCHLORIDE (EQ 1GM BASE)ORALTABLETFalseAB2010-05-24VALACYCLOVIR HYDROCHLORIDE
11ANDA078518_001RXVALACYCLOVIR HYDROCHLORIDE (EQ 500MG BASE)ORALTABLETFalseAB2010-05-24VALACYCLOVIR HYDROCHLORIDE
12ANDA078518_002RXVALACYCLOVIR HYDROCHLORIDE (EQ 1GM BASE)ORALTABLETFalseAB2010-05-24VALACYCLOVIR HYDROCHLORIDE
13ANDA078656_001RXVALACYCLOVIR HYDROCHLORIDE (EQ 500MG BASE)ORALTABLETFalseAB2010-05-24VALACYCLOVIR HYDROCHLORIDE
14ANDA078656_002RXVALACYCLOVIR HYDROCHLORIDE (EQ 1GM BASE)ORALTABLETFalseAB2010-05-24VALACYCLOVIR HYDROCHLORIDE
15ANDA079012_001RXVALACYCLOVIR HYDROCHLORIDE (EQ 500MG BASE)ORALTABLETFalseAB2010-05-24VALACYCLOVIR HYDROCHLORIDE
16ANDA079012_002RXVALACYCLOVIR HYDROCHLORIDE (EQ 1GM BASE)ORALTABLETFalseAB2010-05-24VALACYCLOVIR HYDROCHLORIDE
17ANDA090216_001RXVALACYCLOVIR HYDROCHLORIDE (EQ 500MG BASE)ORALTABLETFalseAB2010-05-24VALACYCLOVIR HYDROCHLORIDE
18ANDA090216_002RXVALACYCLOVIR HYDROCHLORIDE (EQ 1GM BASE)ORALTABLETFalseAB2010-05-24VALACYCLOVIR HYDROCHLORIDE
19ANDA090370_001RXVALACYCLOVIR HYDROCHLORIDE (EQ 500MG BASE)ORALTABLETFalseAB2011-03-16VALACYCLOVIR HYDROCHLORIDE
20ANDA090370_002RXVALACYCLOVIR HYDROCHLORIDE (EQ 1GM BASE)ORALTABLETFalseAB2011-03-16VALACYCLOVIR HYDROCHLORIDE
21ANDA090500_001RXVALACYCLOVIR HYDROCHLORIDE (EQ 500MG BASE)ORALTABLETFalseAB2014-04-04VALACYCLOVIR HYDROCHLORIDE
22ANDA090500_002RXVALACYCLOVIR HYDROCHLORIDE (EQ 1GM BASE)ORALTABLETFalseAB2014-04-04VALACYCLOVIR HYDROCHLORIDE
23ANDA090682_001RXVALACYCLOVIR HYDROCHLORIDE (EQ 500MG BASE)ORALTABLETFalseAB2010-05-24VALACYCLOVIR HYDROCHLORIDE
24ANDA090682_002RXVALACYCLOVIR HYDROCHLORIDE (EQ 1GM BASE)ORALTABLETFalseAB2010-05-24VALACYCLOVIR HYDROCHLORIDE
25ANDA201506_001RXVALACYCLOVIR HYDROCHLORIDE (EQ 500MG BASE)ORALTABLETFalseAB2012-04-03VALACYCLOVIR HYDROCHLORIDE
26ANDA201506_002RXVALACYCLOVIR HYDROCHLORIDE (EQ 1GM BASE)ORALTABLETFalseAB2012-04-03VALACYCLOVIR HYDROCHLORIDE
27ANDA203047_001RXVALACYCLOVIR HYDROCHLORIDE (EQ 500MG BASE)ORALTABLETFalseAB2015-04-08VALACYCLOVIR HYDROCHLORIDE
28ANDA203047_002RXVALACYCLOVIR HYDROCHLORIDE (EQ 1GM BASE)ORALTABLETFalseAB2015-04-08VALACYCLOVIR HYDROCHLORIDE
29NDA020487_001RXVALACYCLOVIR HYDROCHLORIDE (EQ 500MG BASE)ORALTABLETFalseAB1995-06-23VALTREX
30NDA020487_002RXVALACYCLOVIR HYDROCHLORIDE (EQ 1GM BASE)ORALTABLETTrueAB1995-06-23VALTREX

patent(s)

#idexpiration dateapplication(s)
1p5879706 (view patent)2016-01-19NDA020487
2p6107302 (view patent)2016-01-19NDA020487

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10772c392-be52-4d1b-825e-ee321ce9f9cf (view SPL)These highlights do not include all the information needed to use valacyclovir hydrochloride safely and effectively. See full prescribing information for valacyclovir hydrochloride. Valacyclovir hydrochloride tablets Rx only Initial U.S. Approval: 1995prescriptionHuman PrescriptionAidarex Pharmaceuticals Llc2013-10-031532170054
208cc1cdc-b60f-4991-a600-eba70b6f5e72 (view SPL)Valacyclovir Tablets, USP These highlights do not include all the information needed to use valacyclovir tablets safely and effectively. See full prescribing information for Valacyclovir tablets. Valacyclovir hydrochloride (Valacyclovir hydrochloride) TABLET, FILM COATED for ORAL use.Initial U.S. Approval: 1995prescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2013-05-228430630498
311d1e166-9577-47b0-a338-d11ab3ba44aa (view SPL)These highlights do not include all the information needed to use valacyclovir hydrochloride tablets safely and effectively. See full prescribing information for valacyclovir hydrochloride tablets. Valacyclovir hydrochloride tablets Initial U.S. Approval: 1995prescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2011-08-091216950965
41aa34beb-b06b-410c-b483-ba0bd903944a (view SPL)These highlights do not include all the information needed to use valacyclovir hydrochloride tablets safely and effectively. See full prescribing information for valacyclovir hydrochloride tablets. Valacyclovir hydrochloride tablets Initial U.S. Approval: 1995prescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2010-05-241636294468
51ad90fbf-1fae-4f3f-9aea-6a28420e9f10 (view SPL)These highlights do not include all the information needed to use valacyclovir hydrochloride safely and effectively. See full prescribing information for valacyclovir hydrochloride tablets.Valacyclovir Hydrochloride TabletsInitial U.S. Approval: 1995prescriptionHuman PrescriptionMckesson Packaging Services A Business Unit Of Mckesson CorporationREPACK2012-02-212637390525, 637390552
61cc78a3b-6d16-4354-8601-bc10d2b34d02 (view SPL)These highlights do not include all the information needed to use VALTREX safely and effectively. See full prescribing information for VALTREX.VALTREX (valacyclovir hydrochloride) CapletsInitial U.S. Approval: 1995prescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2013-01-211000636293610
71cd5d77f-6478-4176-b703-6bfb3f5cb305 (view SPL)These highlights do not include all the information needed to use valacyclovir hydrochloride safely and effectively. See full prescribing information for valacyclovir tablets, USP. Valacyclovir Tablets, USPInitial U.S. Approval: 1995prescriptionHuman PrescriptionLucid Pharma Llc2013-10-031523430051, 523430052
81ea0a3ac-8876-48c1-e054-00144ff8d46c (view SPL)These highlights do not include all the information needed to use valacyclovir tablets, USP safely and effectively. See full prescribing information for valacyclovir tablets, USP. VALACYCLOVIR TABLETS USP Initial U.S. Approval: 1995prescriptionHuman PrescriptionBlenheim Pharmacal, Inc.repack2015-08-311105440937
921a09954-398a-4514-93c3-7bce55384fa5 (view SPL)These highlights do not include all the information needed to use VALTREX safely and effectively. See full prescribing information for VALTREX.VALTREX (valacyclovir hydrochloride) CapletsInitial U.S. Approval: 1995prescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products LlcREPACK, relabel2012-03-203676499990486
1023fb4162-2310-486c-ba9f-f7c94b793e56 (view SPL)These highlights do not include all the information needed to use valacyclovir hydrochloride safely and effectively. See full prescribing information for valacyclovir tablets, USP. Valacyclovir Tablets, USPInitial U.S. Approval: 1995prescriptionHuman PrescriptionAmerican Health PackagingREPACK2014-03-031680840215, 680840309
1126634bf1-c6d8-4d48-9a4e-845c47df07f8 (view SPL)These highlights do not include all the information needed to use VALACYCLOVIR tablets, USP safely and effectively. See full prescribing information for VALACYCLOVIR tablets, USP.VALACYCLOVIR tablets, USP, for oral use Initial U.S. Approval: 1995prescriptionHuman PrescriptionRnabaxy Pharmaceuticals Inc.api manufacture, manufacture, pack2014-02-2112633040904, 633040905
122d38cbdb-4e4d-4174-461d-7a3b6475e6a5 (view SPL)These highlights do not include all the information needed to use valacyclovir hydrochloride safely and effectively. See full prescribing information for valacyclovir hydrochloride. Valacyclovir Hydrochloride Tablets Initial U.S. Approval: 1995prescriptionHuman PrescriptionDr. Reddy'S Laboratories Ltdanalysis, manufacture2010-09-227551110552, 551110553
132e8d0add-fa4d-4ec1-80d7-29615c76006c (view SPL)These highlights do not include all the information needed to use valacyclovir hydrochloride safely and effectively. See full prescribing information for valacyclovir tablets, USP. Valacyclovir Tablets, USPInitial U.S. Approval: 1995prescriptionHuman PrescriptionAphena Pharma Solutions - Tennessee, LlcRepack2014-07-031433530883
142f0ecd75-e4b4-4493-b7a4-1666fc555c70 (view SPL)These highlights do not include all the information needed to use valacyclovir safely and effectively. See full prescribing information for valacyclovir.VALACYCLOVIR Tablets, USP for Oral UseInitial U.S. Approval: 1995prescriptionHuman PrescriptionMylan Institutional Inc.2014-04-043510790093
152ff6f83c-9794-47dc-b9ea-1d03c02ff812 (view SPL)These highlights do not include all the information needed to use valacyclovir safely and effectively. See full prescribing information for valacyclovir.Valacyclovir Hydrochloride TabletsInitial U.S. Approval: 1995prescriptionHuman PrescriptionCardinal HealthREPACK2014-01-223551545384
163172560a-e692-41f0-9ac3-bf6bfb90c4d6 (view SPL)These highlights do not include all the information needed to use valacyclovir tablets USP safely and effectively. See full prescribing information for valacyclovir tablets USP. VALACYCLOVIR tablets USP, film-coated for oral use Initial U.S. Approval: 1995prescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2015-04-297000937258, 000937259
173277c17e-f953-2b0a-fe0a-4f5d1aeace9d (view SPL)These highlights do not include all the information needed to use valacyclovirtablets, USP safely and effectively. See full prescribing information for valacyclovir tablets, USP. VALACYCLOVIR TABLETS USP Initial U.S. Approval: 1995prescriptionHuman PrescriptionJubilant Cadista Pharmaceuticals, Inc.2012-05-313597460324, 597460325
1833b4df8e-e596-42bc-a116-b36f66a59901 (view SPL)These highlights do not include all the information needed to use valacyclovir tablets, USP safely and effectively. See full prescribing information for valacyclovir tablets, USP. Valacyclovir Tablets, USP for oral use Initial U.S. Approval: 1995prescriptionHuman PrescriptionClinical Solutions Wholesalerepack2015-09-183581185209
193fc60483-3dd9-4d52-a0eb-fceba330e019 (view SPL)These highlights do not include all the information needed to use valacyclovir hydrochloride tablets safely and effectively. See full prescribing information for valacyclovir hydrochloride tablets. Valacyclovir hydrochloride tablets USP Initial U.S. Approval: 1995prescriptionHuman PrescriptionWatson Laboratories, Inc.ANALYSIS, LABEL, PACK2012-11-2914005913248, 005913249
204586efe3-82ab-4f2b-b591-606ee7a4219a (view SPL)These highlights do not include all the information needed to use VALACYCLOVIR tablets, USP safely and effectively. See full prescribing information for VALACYCLOVIR tablets, USP.VALACYCLOVIR tablets, USP, for oral use Initial U.S. Approval: 1995prescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2014-05-231000636294837
21484affc2-a8fe-4430-bb52-00ad678ca8f1 (view SPL)These highlights do not include all the information needed to use VALTREX safely and effectively. See full prescribing information for VALTREX.VALTREX (valacyclovir hydrochloride) CapletsInitial U.S. Approval: 1995prescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2013-01-211000636293982
224acf51de-26f7-42b2-8acc-61b800627ef3 (view SPL)These highlights do not include all the information needed to use valacyclovir hydrochloride safely and effectively. See full prescribing information for valacyclovir tablets, USP. Valacyclovir Tablets, USPInitial U.S. Approval: 1995prescriptionHuman PrescriptionNorthstar Rx LlcANALYSIS, API MANUFACTURE, MANUFACTURE2015-08-176167140697, 167140698
2351f93a1c-90d0-4cbc-90f7-6f1415efd673 (view SPL)These highlights do not include all the information needed to use VALACYCLOVIR tablets, USP safely and effectively. See full prescribing information for VALACYCLOVIR tablets, USP. VALACYCLOVIR tablets, USP, for oral use Initial U.S. Approval: 1995prescriptionHuman PrescriptionOhm Laboratories Inc.api manufacture, manufacture, pack2013-09-241516600904, 516600905
2456bf715d-8280-4557-9f98-9693932199e5 (view SPL)These highlights do not include all the information needed to use valacyclovir safely and effectively. See full prescribing information for valacyclovir.VALACYCLOVIR Tablets, USP for Oral UseInitial U.S. Approval: 1995prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2013-09-278003784275, 003784276
255a0e55c9-950b-4d23-b125-e6ffd42b518f (view SPL)These highlights do not include all the information needed to use valacyclovir hydrochloride tablets safely and effectively. See full prescribing information for valacyclovir hydrochloride tablets. VALACYCLOVIR hydrochloride tablets, film-coated for oral use Initial U.S. Approval: 1995prescriptionHuman PrescriptionMedvantx, Inc.REPACK2012-07-251661160516
2661ea67c2-8c0e-486f-8c0c-6167a1d3d95a (view SPL)These highlights do not include all the information needed to use VALTREX safely and effectively. See full prescribing information for VALTREX.VALTREX (valacyclovir hydrochloride) CapletsInitial U.S. Approval: 1995prescriptionHuman PrescriptionCardinal HealthREPACK2013-06-123551541114
2767d48963-f7bb-438c-9ad6-45f753e3422f (view SPL)These highlights do not include all the information needed to use valacyclovir tablets, USP safely and effectively. See full prescribing information for valacyclovir tablets, USP.Valacyclovir Tablets, USP for oral useInitial U.S. Approval: 1995prescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.REPACK2014-09-151687889432
286b2db776-4f30-4a17-a250-79654b86eca0 (view SPL)These highlights do not include all the information needed to use valacyclovir hydrochloride tablets safely and effectively. See full prescribing information for valacyclovir hydrochloride tablets. Valacyclovir hydrochloride tablets Initial U.S. Approval: 1995prescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2011-04-132216950832
297f5e96e0-534c-47a5-bb79-926088afc73c (view SPL)HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use valacyclovir hydrochloride safely and effectively. See full prescribing information for valacyclovir hydrochloride.Valacyclovir Tablets, USPInitial U.S. Approval:1995prescriptionHuman PrescriptionCamber Pharmaceuticals, Inc.ANALYSIS, MANUFACTURE2015-05-251317220704, 317220705
307f5fc62f-d043-db36-ce92-7adc4f7a79a5 (view SPL)These highlights do not include all the information needed to use valacyclovir hydrochloride safely and effectively. See full prescribing information for valacyclovir tablets, USP. Valacyclovir Tablets, USPInitial U.S. Approval: 1995prescriptionHuman PrescriptionAvpak2014-09-221502680788, 502680789
31823e203e-acc2-4d75-ae42-f33ca2a1bcd1 (view SPL)These highlights do not include all the information needed to use valacyclovir tablets, USP safely and effectively. See full prescribing information for valacyclovir tablets, USP.Valacyclovir Tablets, USP for oral useInitial U.S. Approval: 1995prescriptionHuman PrescriptionSandoz Inc2013-02-185007815208, 007815209
328d1645c0-fd03-4992-9372-98026a26b3af (view SPL)These highlights do not include all the information needed to use valacyclovir hydrochloride safely and effectively. See full prescribing information for valacyclovir tablets, USP. Valacyclovir Tablets, USPInitial U.S. Approval: 1995prescriptionHuman PrescriptionCitron Pharma Llc2014-01-171572370042, 572370043
339d6b1146-e7c6-40d5-abe5-46321f4b9b1a (view SPL)VALACYCLOVIR tablets, USP These highlights do not include all the information needed to use valacyclovir tablets safely and effectively. See full prescribing information for valacyclovir tablets. VALACYCLOVIRtablets, USP, for oral useInitial U.S. Approval: 1995prescriptionHuman PrescriptionActavis Inc.2014-05-2811459630558, 459630559
34a9e1d18e-ad45-4183-bd98-53c7e0b36556 (view SPL)These highlights do not include all the information needed to use valacyclovir hydrochloride safely and effectively. See full prescribing information for valacyclovir hydrochloride. Valacyclovir hydrochloride tablets Rx only Initial U.S. Approval: 1995prescriptionHuman PrescriptionWockhardt LimitedANALYSIS, LABEL, MANUFACTURE, PACK2013-04-032556480152
35b0e6fa63-7b34-4453-a259-34ffd917f4d7 (view SPL)These highlights do not include all the information needed to use valacyclovir hydrochloride tablets safely and effectively. See full prescribing information for valacyclovir hydrochloride tablets. Valacyclovir hydrochloride tablets Initial U.S. Approval: 1995prescriptionHuman PrescriptionLife Line Home Care Services, Inc.relabel, repack2012-03-221759210208
36b28980df-064b-4fd4-8bf3-1589987671ab (view SPL)These highlights do not include all the information needed to use valacyclovir hydrochloride tablets safely and effectively. See full prescribing information for valacyclovir hydrochloride tablets. Valacyclovir hydrochloride tablets Initial U.S. Approval: 1995prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2012-01-037548686089, 548686090
37b4450539-78ec-4e8a-8cfc-56dcde7984a0 (view SPL)These highlights do not include all the information needed to use VALTREX safely and effectively. See full prescribing information for VALTREX.VALTREX (valacyclovir hydrochloride) CapletsInitial U.S. Approval: 1995prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2012-09-042548683804, 548683993
38b4737737-3767-429e-807d-1c2420f3781d (view SPL)These highlights do not include all the information needed to use valacyclovir hydrochloride safely and effectively. See full prescribing information for valacyclovir hydrochloride. Valacyclovir hydrochloride tablets Rx only Initial U.S. Approval: 1995prescriptionHuman PrescriptionCardinal HealthREPACK2014-04-092551544789
39b6b16acc-608a-418a-bf53-f0e44d7f123a (view SPL)These highlights do not include all the information needed to use valacyclovir hydrochloride safely and effectively. See full prescribing information for valacyclovir hydrochloride. Valacyclovir hydrochloride tablets Rx only Initial U.S. Approval: 1995prescriptionHuman PrescriptionWockhardt Usa Llc.ANALYSIS, LABEL, MANUFACTURE, PACK2013-04-032646790152
40bcea5540-f9cf-489c-9039-2b15d127e412 (view SPL)Valacyclovir Tablets, USPThese highlights do not include all the information needed to use valacyclovir tablets safely and effectively. See full prescribing information for Valacyclovir tablets.Valacyclovir hydrochloride (Valacyclovir hydrochloride) TABLET, FILM COATED for ORAL use.Initial U.S. Approval: 1995prescriptionHuman PrescriptionRemedyrepack Inc.2013-12-041521250617
41bcfc31a1-b604-4cd1-a9e0-681e60d4cd2e (view SPL)These highlights do not include all the information needed to use valacyclovir hydrochloride tablets safely and effectively. See full prescribing information for valacyclovir hydrochloride tablets. Valacyclovir hydrochloride tablets Initial U.S. Approval: 1995prescriptionHuman PrescriptionH.J. Harkins Company, Inc.relabel, repack2012-04-185529590303
42bdd38bb5-ff30-4392-a151-5234b9342304 (view SPL)These highlights do not include all the information needed to use valacyclovir hydrochloride tablets safely and effectively. See full prescribing information for valacyclovir hydrochloride tablets. VALACYCLOVIR hydrochloride tablets, film-coated for oral use Initial U.S. Approval: 1995prescriptionHuman PrescriptionState Of Florida Doh Central Pharmacyrepack2013-10-011538080635
43bde79448-2feb-4f61-b390-5ef9fb142995 (view SPL)These highlights do not include all the information needed to use VALACYCLOVIR TABLETS, USP safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS, USP. VALACYCLOVIR TABLETS, USPInitial U.S. Approval: 1995prescriptionHuman PrescriptionRemedyrepack Inc.2015-05-201617860297
44c5d2d5e0-4a7c-4d54-b155-c34076302854 (view SPL)These highlights do not include all the information needed to use valacyclovir hydrochloride safely and effectively. See full prescribing information for valacyclovir hydrochloride. Valacyclovir hydrochloride tablets Rx only Initial U.S. Approval: 1995prescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.REPACK2014-02-172687889554
45c7db0cf5-10f0-46e6-98a8-8d8c6cde4227 (view SPL)These highlights do not include all the information needed to use valacyclovir hydrochloride safely and effectively. See full prescribing information for valacyclovir hydrochloride tablets.Valacyclovir Hydrochloride TabletsInitial U.S. Approval: 1995prescriptionHuman PrescriptionCardinal HealthREPACK2015-01-211551546837
46c89fdb3a-99cb-4e47-88bb-782f5e402f15 (view SPL)These highlights do not include all the information needed to use valacyclovir hydrochloride tablets safely and effectively. See full prescribing information for valacyclovir hydrochloride tablets.Valacyclovir hydrochloride tablets Initial U.S. Approval: 1995prescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2011-07-156430630200
47cbd7bb49-7a9c-4383-a158-bfc307db0130 (view SPL)ValacyclovirprescriptionHuman PrescriptionDirect Rxrelabel, repack2015-08-031619190066
48cbd9d853-d138-4bfa-b5b8-5f5b9699dc77 (view SPL)Valacyclovir Tablets, USPThese highlights do not include all the information needed to use Valacyclovir hydrochloride safely and effectively. See full prescribing information for Valacyclovir hydrochloride.Valacyclovir hydrochloride (Valacyclovir hydrochloride) TABLET, FILM COATED for ORAL use.Initial U.S. Approval: 1995prescriptionHuman PrescriptionRemedyrepack Inc.2013-04-091493490886
49cd8629b9-a51a-49a1-8521-274f75897a71 (view SPL)Valacyclovir Tablets, USPThese highlights do not include all the information needed to use valacyclovir tablets safely and effectively. See full prescribing information for Valacyclovir tablets.Valacyclovir hydrochloride (Valacyclovir hydrochloride) TABLET, FILM COATED for ORAL use.Initial U.S. Approval: 1995prescriptionHuman PrescriptionRemedyrepack Inc.2013-05-292521250617
50cf0ca407-3a63-4741-ba63-8f164f797b79 (view SPL)VALACYCLOVIR tablets, USP These highlights do not include all the information needed to use valacyclovir tablets safely and effectively. See full prescribing information for valacyclovir tablets. VALACYCLOVIRtablets, USP, for oral useInitial U.S. Approval: 1995prescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2014-05-2815430630534
51d7aa2791-95d9-4732-afe4-89d70f01d152 (view SPL)These highlights do not include all the information needed to use valacyclovir hydrochloride safely and effectively. See full prescribing information for valacyclovir hydrochloride tablets.Valacyclovir Hydrochloride TabletsInitial U.S. Approval: 1995prescriptionHuman PrescriptionMedvantx, Inc.REPACK2010-12-131661160482
52d8028584-4186-41d6-b74b-2535971aa216 (view SPL)These highlights do not include all the information needed to use VALTREX safely and effectively. See full prescribing information for VALTREX.VALTREX (valacyclovir hydrochloride) CapletsInitial U.S. Approval: 1995prescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2011-12-168552890926
53d8242d35-ee3a-4008-81a0-70cdd84a1e7c (view SPL)VALACYCLOVIR tablets, USP These highlights do not include all the information needed to use valacyclovir tablets safely and effectively. See full prescribing information for valacyclovir tablets. VALACYCLOVIRtablets, USP, for oral useInitial U.S. Approval: 1995prescriptionHuman PrescriptionProficient Rx LpRELABEL, REPACK2014-03-271631870311
54d94db477-23c6-418a-9226-125c8552a947 (view SPL)These highlights do not include all the information needed to use valacyclovir hydrochloride safely and effectively. See full prescribing information for valacyclovir tablets, USP. Valacyclovir Tablets, USPInitial U.S. Approval: 1995prescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrelabel2015-09-301557000045
55e228913a-8f12-4a4f-bc14-ba44d6e9ece9 (view SPL)These highlights do not include all the information needed to use Valacyclovir Tablets USP safely and effectively. See full prescribing information for Valacyclovir Tablets USP.Valacyclovir Tablets USP, for oral administrationInitial U.S. Approval: 1995prescriptionHuman PrescriptionRoxane Laboratories, IncMANUFACTURE2015-07-295000540114, 000540115
56ea5f09e7-8060-4ce4-89fb-aaf2fa0e21e1 (view SPL)prescriptionHuman PrescriptionNorthwind Pharmaceuticals, Llcrepack2014-05-061516550955
57efe37bd1-a236-43cc-828c-b57e8a704d67 (view SPL)These highlights do not include all the information needed to use valacyclovirtablets, USP safely and effectively. See full prescribing information for valacyclovir tablets, USP. VALACYCLOVIR TABLETSUSPInitial U.S. Approval: 1995prescriptionHuman PrescriptionProficient Rx LpRELABEL, REPACK2015-02-011631870538
58f08bac58-5633-4e79-9524-838260e4a0b8 (view SPL)These highlights do not include all the information needed to use valacyclovir hydrochloride safely and effectively. See full prescribing information for valacyclovir hydrochloride. Valacyclovir hydrochloride tablets Rx only Initial U.S. Approval: 1995prescriptionHuman PrescriptionAmerican Health PackagingREPACK2013-11-112680840633, 680840634
59f5cfb61e-d971-4a9c-b9ef-4f3368fe02f5 (view SPL)These highlights do not include all the information needed to use valacyclovir hydrochloride safely and effectively. See full prescribing information for valacyclovir tablets, USP. Valacyclovir Tablets, USPInitial U.S. Approval: 1995prescriptionHuman PrescriptionAurobindo Pharma LimitedANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK, RELABEL, REPACK2012-06-127658620448, 658620449
60f8e0d8f8-cb73-4206-a484-88f5c4fbd719 (view SPL)These highlights do not include all the information needed to use VALTREX safely and effectively. See full prescribing information for VALTREX.VALTREX (valacyclovir hydrochloride) CapletsInitial U.S. Approval: 1995prescriptionHuman PrescriptionGlaxosmithkline Llc2013-12-0316001730565, 001730933
61fa2f4056-3503-419d-a1eb-0f2474a61948 (view SPL)These highlights do not include all the information needed to use VALACYCLOVIR TABLETS, USP safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS, USP. VALACYCLOVIR TABLETS, USPInitial U.S. Approval: 1995prescriptionHuman PrescriptionCipla Usa Inc.2014-11-262690970153
62fc20acce-c989-42d3-8508-3230a9c8f9a5 (view SPL)These highlights do not include all the information needed to use valacyclovirtablets, USP safely and effectively. See full prescribing information for valacyclovir tablets, USP. VALACYCLOVIR TABLETSUSPInitial U.S. Approval: 1995prescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.REPACK2015-05-041687889984

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII