Acyclovir Oral Capsule

Brand(s)
Zovirax
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Prestium Pharma, Inc. (2014-02-10)
Oldest Current Product
1997-04-22
License(s)
NDA, ANDA, EXPORT ONLY
RxNORM
ORAL CAPSULE\ACYCLOVIR
FDAOB
ORAL\CAPSULE\ACYCLOVIR
SPL Active
ORAL\CAPSULE\ACYCLOVIR
SPL Moiety
ORAL\CAPSULE\ACYCLOVIR

product(s) by strength(s)

acyclovir 200 mg oral capsule

export only product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formspl
1620330204EXPORT ONLYBoscogen, Inc.2004-08-01ACYCLOVIRORALCAPSULEf5174611-2734-4610-b12f-eb5a7f39d7b6

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1400760991ZoviraxNDAPrestium Pharma, Inc.2014-02-07ACYCLOVIRORALCAPSULENDA0188286fe0ab86-9d81-461e-9c84-6ba724a91318

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000938940ANDATeva Pharmaceuticals Usa Inc1997-04-23ACYCLOVIRORALCAPSULEANDA074578f0d8278e-f521-451b-9093-16571eccd284
2009045789ANDAMajor2007-04-19ACYCLOVIRORALCAPSULEANDA075677864d96b9-e2de-45a8-850b-6f7b72ceefe1
3231550146ANDAHeritage Pharmaceuticals Inc.2010-06-14ACYCLOVIRORALCAPSULEANDA075090de024b17-89ed-4480-92a6-4e287c813fdc
4605050042ANDAApotex Corp2006-03-20ACYCLOVIRORALCAPSULEANDA07567741bea43a-f58c-2c6f-4d31-406ceb456077
5614420111ANDACarlsbad Technology, Inc.2009-10-22ACYCLOVIRORALCAPSULEANDA075090cc9c128a-1c84-4078-9182-c01cbd7a0040
6633040652ANDARnabaxy Pharmaceuticals Inc.1999-02-08ACYCLOVIRORALCAPSULEANDA074975d13b8cdd-59fd-472b-8125-a19f42ef5402
7656910089ANDACadila Pharmaceuticals Limited2014-03-11ACYCLOVIRORALCAPSULEANDA20144534040ab6-c095-4dd1-bb2f-a20e4b801d43
8672530100ANDADava Pharmaceuticals, Inc.1997-04-22ACYCLOVIRORALCAPSULEANDA0748337008d09b-c551-4851-b131-cf1e785c944e
9690760146ANDAQuinn Pharmaceuticals, Llc2015-02-01ACYCLOVIRORALCAPSULEANDA0750909ad711e4-003d-4b58-8177-32928bc42aa9

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1231550229ANDAHeritage Pharmaceuticals Inc.2014-06-02ACYCLOVIRORALCAPSULEANDA07488985332671-0e3a-4445-a337-e1266886b9cf

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1105440101ANDABlenheim Pharmacal, Inc.2011-02-15ACYCLOVIRORALCAPSULE000938940ANDA074578407bcc5d-d2a7-4258-bc96-7d162de00636
2105440146ANDABlenheim Pharmacal, Inc.2013-11-11ACYCLOVIRORALCAPSULE605050042ANDA0756779e9138ff-b3ea-4dba-9458-8a644a6a6171
3216950009ANDARebel Distributors Corp1998-10-30ACYCLOVIRORALCAPSULE633040652ANDA074975a2db7131-bf31-47bf-bf61-594f919af1f2
4332610419ANDAAidarex Pharmaceuticals Llc1997-04-23ACYCLOVIRORALCAPSULE000938940ANDA07457868227df2-cac6-4799-8dcd-8c2f42204315
5422910107ANDAAvkare, Inc.2013-07-08ACYCLOVIRORALCAPSULE614420111ANDA075090e49c0871-56ce-e61f-c5e3-f5f4b5b26bd2
6430630204ANDAPd-Rx Pharmaceuticals, Inc.2010-03-23ACYCLOVIRORALCAPSULE003782200ANDA0747271a7332f2-c91d-447a-aecc-411ecb53dc44
7493490269ANDARemedyrepack Inc.2011-05-09ACYCLOVIRORALCAPSULE672530100ANDA07509084f74103-3e89-4b8b-a2fb-d7ed13e03521
8493490377ANDARemedyrepack Inc.2011-07-14ACYCLOVIRORALCAPSULE614420111ANDA0750900bc0744a-4db3-490f-a0cd-16c465dccf8f
9493490620ANDARemedyrepack Inc.2011-12-06ACYCLOVIRORALCAPSULE000938940ANDA07457829ff5c13-7291-4788-811e-946c8f530b75
10502680060ANDAAvpak2013-05-02ACYCLOVIRORALCAPSULE614420111ANDA0750909496797c-74dd-4f74-c4ed-c311cc1be740
11529590517ANDAH.J. Harkins Company, Inc.2011-05-27ACYCLOVIRORALCAPSULE000938940ANDA0745782f9d7db0-6dee-47b6-be50-9192204daf4d
12548683996ANDAPhysicians Total Care, Inc.1998-07-27ACYCLOVIRORALCAPSULE003782200ANDA074727303c1dba-7c14-4fc9-9e87-a9b705168491
13551544329ANDACardinal Health2013-05-02ACYCLOVIRORALCAPSULE502680060ANDA075090fbba8a99-51d5-4d7d-9fd6-8ac81ef3c989
14551548294ANDACardinal Health2011-12-07ACYCLOVIRORALCAPSULE000938940ANDA07457870894da8-4669-4847-b1d6-590a4bfad9b7
15552890273ANDAPd-Rx Pharmaceuticals, Inc.1997-04-23ACYCLOVIRORALCAPSULE000938940ANDA07457820f3675c-ff45-49e5-aea0-9189c5c9b6b6
16604290012ANDAGolden State Medical Supply, Inc.2012-09-20ACYCLOVIRORALCAPSULE605050042ANDA0756776b622287-7e28-4a21-9ace-4bbd7a5596b4
17604290711ANDAGolden State Medical Supply, Inc.1997-04-22ACYCLOVIRORALCAPSULE672530100ANDA074833f7c4592e-205a-493a-857a-62f32d75176c
18604290911ANDAGolden State Medical Supply, Inc.1999-01-26ACYCLOVIRORALCAPSULE614420111ANDA0750901dd310b2-9697-464d-8fee-20d909c367ac
19617860088ZoviraxNDARemedyrepack Inc.2014-11-10ACYCLOVIRORALCAPSULE001730991NDA01882842511ffa-d9ad-42ef-92e0-bbe966c4baf7
20617860186ZoviraxNDARemedyrepack Inc.2015-02-16ACYCLOVIRORALCAPSULE400760991NDA018828b68df3f5-8448-4854-a6f1-09b99758be9f
21617860187ANDARemedyrepack Inc.2015-02-16ACYCLOVIRORALCAPSULE605050042ANDA07567711b44c07-ae40-44e4-a1fb-717050994c32
22631870154ANDAProficient Rx Lp1997-04-23ACYCLOVIRORALCAPSULE000938940ANDA0745780d088c7f-d806-49da-a34a-46d86e6ca173
23631870182ANDAProficient Rx Lp2009-10-22ACYCLOVIRORALCAPSULE614420111ANDA075090b2c19660-4f9e-48e2-9918-5954962c45ab
24636291676ANDABryant Ranch Prepack1997-04-23ACYCLOVIRORALCAPSULE000938940ANDA074578d700c8a9-bc79-4940-82ee-25163bdcf31b
25680840107ANDAAmerican Health Packaging2014-01-29ACYCLOVIRORALCAPSULE605050042ANDA0756779d16ea0c-5b51-43b8-bf1a-bee84a6a764b
26687889690ANDAPreferred Pharmaceuticals, Inc.2013-03-26ACYCLOVIRORALCAPSULE614420111ANDA075090e7591486-afb6-495a-889e-e6c5a8581786

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA074570ACYCLOVIRTrueROXANE LABORATORIES INC1997-04-22ANDA074570_002
2ANDA074578ACYCLOVIRTEVA PHARMACEUTICALS USA INC1997-04-22ANDA074578_001
3ANDA074674ACYCLOVIRTrueIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA1997-04-22ANDA074674_001
4ANDA074727ACYCLOVIRMYLAN PHARMACEUTICALS INC1997-04-22ANDA074727_001
5ANDA074750ACYCLOVIRTrueLEK PHARMACEUTICAL AND CHEMICAL CO DD1997-04-22ANDA074750_001
6ANDA074828ACYCLOVIRTrueTEVA PHARMACEUTICALS USA INC1997-04-22ANDA074828_001
7ANDA074833ACYCLOVIRDAVA PHARMACEUTICALS INC1997-04-22ANDA074833_001
8ANDA074872ACYCLOVIRTrueDAVA PHARMACEUTICALS INC1997-04-22ANDA074872_001
9ANDA074889ACYCLOVIRTrueHERITAGE PHARMACEUTICALS INC1997-10-31ANDA074889_001
10ANDA074906ACYCLOVIRTrueACTAVIS ELIZABETH LLC1997-08-26ANDA074906_001
11ANDA074914ACYCLOVIRTrueTEVA PHARMACEUTICALS USA1997-11-26ANDA074914_001
12ANDA074975ACYCLOVIRRANBAXY LABORATORIES LTD1998-09-30ANDA074975_001
13ANDA074977ACYCLOVIRTrueMYLAN PHARMACEUTICALS INC1998-04-13ANDA074977_001
14ANDA075090ACYCLOVIRSTASON INDUSTRIAL CORP1999-01-26ANDA075090_001
15ANDA075101ACYCLOVIRTrueWATSON LABORATORIES INC1998-04-15ANDA075101_001
16ANDA075677ACYCLOVIRAPOTEX INC ETOBICOKE SITE2005-09-28ANDA075677_001
17ANDA201445ACYCLOVIRCADILA PHARMACEUTICALS LTD2014-03-06ANDA201445_001
18NDA018828ZOVIRAXDELCOR ASSET CORP1985-01-25NDA018828_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA074570_002discontinuedACYCLOVIR (200MG)ORALCAPSULEFalse1997-04-22ACYCLOVIR
2ANDA074578_001RXACYCLOVIR (200MG)ORALCAPSULEFalseAB1997-04-22ACYCLOVIR
3ANDA074674_001discontinuedACYCLOVIR (200MG)ORALCAPSULEFalse1997-04-22ACYCLOVIR
4ANDA074727_001RXACYCLOVIR (200MG)ORALCAPSULEFalseAB1997-04-22ACYCLOVIR
5ANDA074750_001discontinuedACYCLOVIR (200MG)ORALCAPSULEFalse1997-04-22ACYCLOVIR
6ANDA074828_001discontinuedACYCLOVIR (200MG)ORALCAPSULEFalse1997-04-22ACYCLOVIR
7ANDA074833_001RXACYCLOVIR (200MG)ORALCAPSULEFalseAB1997-04-22ACYCLOVIR
8ANDA074872_001discontinuedACYCLOVIR (200MG)ORALCAPSULEFalse1997-04-22ACYCLOVIR
9ANDA074889_001discontinuedACYCLOVIR (200MG)ORALCAPSULEFalse1997-10-31ACYCLOVIR
10ANDA074906_001discontinuedACYCLOVIR (200MG)ORALCAPSULEFalse1997-08-26ACYCLOVIR
11ANDA074914_001discontinuedACYCLOVIR (200MG)ORALCAPSULEFalse1997-11-26ACYCLOVIR
12ANDA074975_001RXACYCLOVIR (200MG)ORALCAPSULEFalseAB1998-09-30ACYCLOVIR
13ANDA074977_001discontinuedACYCLOVIR (200MG)ORALCAPSULEFalse1998-04-13ACYCLOVIR
14ANDA075090_001RXACYCLOVIR (200MG)ORALCAPSULEFalseAB1999-01-26ACYCLOVIR
15ANDA075101_001discontinuedACYCLOVIR (200MG)ORALCAPSULEFalse1998-04-15ACYCLOVIR
16ANDA075677_001RXACYCLOVIR (200MG)ORALCAPSULEFalseAB2005-09-28ACYCLOVIR
17ANDA201445_001RXACYCLOVIR (200MG)ORALCAPSULEFalseAB2014-03-06ACYCLOVIR
18NDA018828_001RXACYCLOVIR (200MG)ORALCAPSULETrueAB1985-01-25ZOVIRAX

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
10bc0744a-4db3-490f-a0cd-16c465dccf8f (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2011-07-141493490377
20d088c7f-d806-49da-a34a-46d86e6ca173 (view SPL)ACYCLOVIR CAPSULES USP ACYCLOVIR TABLETS USP 8940 8943 8947 Rx onlyprescriptionHuman PrescriptionProficient Rx LpRELABEL, REPACK2014-08-011631870154
311b44c07-ae40-44e4-a1fb-717050994c32 (view SPL)ACYCLOVIR CAPSULES USP200 mgprescriptionHuman PrescriptionRemedyrepack Inc.2015-02-161617860187
41a7332f2-c91d-447a-aecc-411ecb53dc44 (view SPL)prescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2010-02-112430630204
51dd310b2-9697-464d-8fee-20d909c367ac (view SPL)ACYCLOVIR Capsules, USPprescriptionHuman PrescriptionGolden State Medical Supply, Inc.RELABEL, REPACK2012-01-091604290911
620f3675c-ff45-49e5-aea0-9189c5c9b6b6 (view SPL)ACYCLOVIRCAPSULES USPACYCLOVIRTABLETS USP894089438947Rx onlyprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2013-02-0811552890273
729ff5c13-7291-4788-811e-946c8f530b75 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2011-12-061493490620
82f9d7db0-6dee-47b6-be50-9192204daf4d (view SPL)ACYCLOVIRCAPSULES USPACYCLOVIRTABLETS USP894089438947Rx onlyprescriptionHuman PrescriptionH.J. Harkins Company, Inc.manufacture2011-10-271529590517
9303c1dba-7c14-4fc9-9e87-a9b705168491 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2012-09-253548683996, 548683997, 548683998Acyclovir Oral Tablet
1034040ab6-c095-4dd1-bb2f-a20e4b801d43 (view SPL)prescriptionHuman PrescriptionCadila Pharmaceuticals LimitedANALYSIS, API MANUFACTURE, API/FDF ANALYTICAL TESTING, CLINICAL BIOEQUIVALENCE OR BIOAVAILABILITY STUDY, FDF MANUFACTURE, LABEL, MANUFACTURE, PACK2014-03-115656910089
11407bcc5d-d2a7-4258-bc96-7d162de00636 (view SPL)ACYCLOVIRCAPSULES USPACYCLOVIRTABLETS USP894089438947Rx onlyprescriptionHuman PrescriptionBlenheim Pharmacal, Inc.repack2011-04-292105440101
1241bea43a-f58c-2c6f-4d31-406ceb456077 (view SPL)ACYCLOVIR CAPSULES USP200 mgprescriptionHuman PrescriptionApotex Corpanalysis, manufacture2012-04-092605050042
1342511ffa-d9ad-42ef-92e0-bbe966c4baf7 (view SPL)ZOVIRAX(acyclovir) CapsulesZOVIRAX(acyclovir) TabletsZOVIRAX(acyclovir) SuspensionprescriptionHuman PrescriptionRemedyrepack Inc.2014-11-101617860088
1468227df2-cac6-4799-8dcd-8c2f42204315 (view SPL)ACYCLOVIRCAPSULES USPACYCLOVIRTABLETS USP894089438947Rx onlyprescriptionHuman PrescriptionAidarex Pharmaceuticals Llc2012-09-103332610419, 332610227, 332610491Acyclovir Oral Tablet
156b622287-7e28-4a21-9ace-4bbd7a5596b4 (view SPL)ACYCLOVIR CAPSULES USP200 MGprescriptionHuman PrescriptionGolden State Medical Supply, Inc.RELABEL, REPACK2013-01-031604290012
166fe0ab86-9d81-461e-9c84-6ba724a91318 (view SPL)ZOVIRAX (acyclovir) Capsules ZOVIRAX (acyclovir) Tablets ZOVIRAX (acyclovir) SuspensionprescriptionHuman PrescriptionPrestium Pharma, Inc.MANUFACTURE2014-02-101400760991, 400760945, 400760949, 400760953Acyclovir Oral Suspension
Acyclovir Oral Tablet
177008d09b-c551-4851-b131-cf1e785c944e (view SPL)ACYCLOVIR CAPSULES AND TABLETS Rx OnlyprescriptionHuman PrescriptionDava Pharmaceuticals, Inc.ANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2014-04-012672530100, 672530101, 672530102Acyclovir Oral Tablet
1870894da8-4669-4847-b1d6-590a4bfad9b7 (view SPL)ACYCLOVIRCAPSULES USPACYCLOVIRTABLETS USP894089438947Rx onlyprescriptionHuman PrescriptionCardinal HealthREPACK2013-03-062551548294, 551548295Acyclovir Oral Tablet
1984f74103-3e89-4b8b-a2fb-d7ed13e03521 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2011-05-091493490269
2085332671-0e3a-4445-a337-e1266886b9cf (view SPL)Acyclovir Capsules, USPprescriptionHuman PrescriptionHeritage Pharmaceuticals Inc.MANUFACTURE2015-07-072231550229
21864d96b9-e2de-45a8-850b-6f7b72ceefe1 (view SPL)ACYCLOVIR CAPSULES USP200 mgprescriptionHuman PrescriptionMajor2013-09-161009045789
229496797c-74dd-4f74-c4ed-c311cc1be740 (view SPL)Acyclovir Capsules USPprescriptionHuman PrescriptionAvpak2014-09-102502680060
239ad711e4-003d-4b58-8177-32928bc42aa9 (view SPL)Acyclovir Capsules USPRx onlyprescriptionHuman PrescriptionQuinn Pharmaceuticals, Llcmanufacture2015-02-011690760146
249d16ea0c-5b51-43b8-bf1a-bee84a6a764b (view SPL)ACYCLOVIR CAPSULES USP 200 mgprescriptionHuman PrescriptionAmerican Health PackagingREPACK2014-01-301680840107
259e9138ff-b3ea-4dba-9458-8a644a6a6171 (view SPL)ACYCLOVIR CAPSULES USP200 MGprescriptionHuman PrescriptionBlenheim Pharmacal, Inc.RELABEL, REPACK2014-01-011105440146
26a2db7131-bf31-47bf-bf61-594f919af1f2 (view SPL)AcyclovirprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2011-01-051216950009, 216950010, 216950011Acyclovir Oral Tablet
27b2c19660-4f9e-48e2-9918-5954962c45ab (view SPL)Acyclovir Capsules USPprescriptionHuman PrescriptionProficient Rx LpRELABEL, REPACK2015-02-011631870182
28b68df3f5-8448-4854-a6f1-09b99758be9f (view SPL)ZOVIRAX(acyclovir) CapsulesZOVIRAX(acyclovir) TabletsZOVIRAX(acyclovir) SuspensionprescriptionHuman PrescriptionRemedyrepack Inc.2015-02-161617860186
29cc9c128a-1c84-4078-9182-c01cbd7a0040 (view SPL)Acyclovir Capsules USPprescriptionHuman PrescriptionCarlsbad Technology, Inc.2015-04-074614420111
30d13b8cdd-59fd-472b-8125-a19f42ef5402 (view SPL)ACYCLOVIR CAPSULES, USP AND ACYCLOVIR TABLETS, USPRx onlyprescriptionHuman PrescriptionRnabaxy Pharmaceuticals Inc.manufacture2013-09-065633040652, 633040504, 633040505Acyclovir Oral Tablet
31d700c8a9-bc79-4940-82ee-25163bdcf31b (view SPL)ACYCLOVIRCAPSULES USPACYCLOVIRTABLETS USP894089438947Rx onlyprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2014-07-181001636291676
32de024b17-89ed-4480-92a6-4e287c813fdc (view SPL)Acyclovir CapsulesprescriptionHuman PrescriptionHeritage Pharmaceuticals Inc.manufacture2010-05-211231550146
33e49c0871-56ce-e61f-c5e3-f5f4b5b26bd2 (view SPL)Acyclovir Capsules USPprescriptionHuman PrescriptionAvkare, Inc.2013-07-082422910107
34e7591486-afb6-495a-889e-e6c5a8581786 (view SPL)Acyclovir Capsules USPprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.REPACK2013-03-261687889690
35f0d8278e-f521-451b-9093-16571eccd284 (view SPL)ACYCLOVIR CAPSULES USP ACYCLOVIR TABLETS USP 894089438947 Rx onlyprescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2015-01-2314000938940, 000938943, 000938947Acyclovir Oral Tablet
36f5174611-2734-4610-b12f-eb5a7f39d7b6 (view SPL)Acyclovir CapsulesprescriptionHuman PrescriptionBoscogen, Inc.2011-01-052620330204
37f7c4592e-205a-493a-857a-62f32d75176c (view SPL)ACYCLOVIR Capsules, USPprescriptionHuman PrescriptionGolden State Medical Supply, Inc.RELABEL, REPACK2011-07-012604290711
38fbba8a99-51d5-4d7d-9fd6-8ac81ef3c989 (view SPL)Acyclovir Capsules USPprescriptionHuman PrescriptionCardinal HealthREPACK2014-07-081551544329

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