Temazepam Oral Capsule

Brand(s)
Restoril
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Mallinckrodt, Inc. (2014-11-30)
Oldest Current Product
1986-07-10
License(s)
NDA, ANDA
RxNORM
ORAL CAPSULE\TEMAZEPAM
FDAOB
ORAL\CAPSULE\TEMAZEPAM
SPL Active
ORAL\CAPSULE\TEMAZEPAM
SPL Moiety
ORAL\CAPSULE\TEMAZEPAM

product(s) by strength(s)

temazepam 15 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004069916RestorilNDAMallinckrodt, Inc.2011-07-07TEMAZEPAMORALCAPSULENDA018163bc56f7fd-1aaf-48ff-8aa7-d467e59e1015

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1002282076ANDAActavis Elizabeth Llc1995-01-23TEMAZEPAMORALCAPSULEANDA071638a4370eb4-b00d-4247-af8d-980e59fbbec6
2003784010ANDAMylan Pharmaceuticals Inc.1986-07-10TEMAZEPAMORALCAPSULEANDA070920a5416154-8490-4e84-bb6f-4ff0cc605214
3006035892ANDAQualitest Pharmaceuticals2015-07-31TEMAZEPAMORALCAPSULEANDA201781471fa2f1-73a0-49be-89f3-d3e2cfdaeca0
4007812201ANDASandoz Inc1988-01-12TEMAZEPAMORALCAPSULEANDA071427fe3a8ab5-8603-4d8e-922c-7a41fbb815a5
5400320121ANDANovel Laboratories, Inc.2009-10-01TEMAZEPAMORALCAPSULEANDA07145685327378-86a3-4448-9185-e20bb20ebf45
6534890649ANDAMutual Pharmaceutical Company, Inc.2006-10-26TEMAZEPAMORALCAPSULEANDA0711753e4a35f8-77e5-4c9a-aad2-b0aeb98edd66
7678770146ANDAAscend Laboratories, Llc1987-04-21TEMAZEPAMORALCAPSULEANDA0714568f54731f-c5b7-492c-acb0-444c5fbb7029

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1001791470ANDAKaiser Foundations Hospitals2003-06-02TEMAZEPAMORALCAPSULE002282076ANDA07163840b2ff05-3d35-4cd7-a525-0f8b507ac178
2006157808ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs1988-01-12TEMAZEPAMORALCAPSULE007812201ANDA07142770aaf6b1-91c9-4a5a-82c8-3c34c4e1dfe3
3165900214ANDAStat Rx Usa Llc1987-08-07TEMAZEPAMORALCAPSULE002282076ANDA071638f0f4184e-e7e1-49e6-9b93-ac599ac524c6
4216950282ANDARebel Distributors Corp1987-04-21TEMAZEPAMORALCAPSULE678770146ANDA0714566979644e-0587-4040-b754-5dce5eda87a4
5333580332ANDARxchange Co.2014-11-15TEMAZEPAMORALCAPSULE002282076ANDA071638c270129a-03e8-4c3d-a47e-0e533f05b2ad
6353560664ANDALake Erie Medical Dba Quality Care Products Llc1987-04-21TEMAZEPAMORALCAPSULE678770146ANDA071456bcfd6a3d-66eb-4844-bede-6ec671985b2c
7425490651ANDAStat Rx Usa Llc2010-05-24TEMAZEPAMORALCAPSULE003784010ANDA07092055f28be9-7d69-467c-b5de-6e281ca9c498
8499990045ANDALake Erie Medical Dba Quality Care Products Llc2011-08-03TEMAZEPAMORALCAPSULE003784010ANDA070920b9d4ff6b-4e36-4530-8b67-4403ed2d357e
9500900186ANDAA-S Medication Solutions Llc1987-04-21TEMAZEPAMORALCAPSULE678770146ANDA07145619b2711e-587a-47d2-ab62-d564e7b87195
10504364628ANDAUnit Dose Services1987-08-03TEMAZEPAMORALCAPSULE002282076ANDA071638dbd39517-62f5-44b0-844f-e1cbf3c6ca2e
11510790418ANDAMylan Institutional Inc.1997-04-29TEMAZEPAMORALCAPSULE003784010ANDA070920a4a2e4e3-6213-4d72-bbdc-7c1447283e2b
12521250198ANDARemedyrepack Inc.2013-03-26TEMAZEPAMORALCAPSULE003784010ANDA07092047ff9717-042f-4df3-864e-3cd6ef19d33a
13521250881ANDARemedyrepack Inc.2014-03-19TEMAZEPAMORALCAPSULE003784010ANDA0709205da409a5-bb7b-4881-a3d7-044b4f75d6a0
14529590535ANDAH.J. Harkins Company, Inc.1987-04-21TEMAZEPAMORALCAPSULE678770146ANDA0714562ed81194-be24-45a0-8dde-fbc6ad3d7abe
15545690905ANDAA-S Medication Solutions Llc1987-04-21TEMAZEPAMORALCAPSULE678770146ANDA07145667040aa9-3a87-4c8a-882c-4b637a69d0b6
16548680038ANDAPhysicians Total Care, Inc.2008-01-10TEMAZEPAMORALCAPSULE003784010ANDA07092030dadf97-4e8c-4630-b362-940313a8852e
17551543445ANDACardinal Health1988-01-12TEMAZEPAMORALCAPSULE007812201ANDA0714272b673d8e-d16e-4a73-b7e3-0f1cc1f058df
18551545591ANDACardinal Health2011-02-04TEMAZEPAMORALCAPSULE510790418ANDA070920a4ee3907-45d4-41b9-af8a-39a9966cd533
19551546264ANDACardinal Health2012-10-25TEMAZEPAMORALCAPSULE003784010ANDA070920eeb9df6c-e8a7-470e-99d4-9c0495554720
20604290506ANDAGolden State Medical Supply, Inc.2014-01-10TEMAZEPAMORALCAPSULE002282076ANDA071638abdeee37-d0d8-4f22-a977-f8ea37c51f03
21619190214ANDADirect Rx2014-01-01TEMAZEPAMORALCAPSULE002282076ANDA07163874f261c5-a960-44ef-be4c-4dcefd881c3f
22619190263ANDADirect Rx2015-01-01TEMAZEPAMORALCAPSULE678770146ANDA071456f7c31cab-c96b-45e1-8c29-48e17b3fd731
23631870132ANDAProficient Rx Lp1987-04-21TEMAZEPAMORALCAPSULE678770146ANDA071456904b8986-24da-48eb-bb0a-33d41b4eb005
24636291619ANDABryant Ranch Prepack1987-04-21TEMAZEPAMORALCAPSULE678770146ANDA0714561c08d30d-7c27-a09a-5240-7050771d5cc7
25637390231ANDAMckesson Packaging Services A Business Unit Of Mckesson Corporation2007-09-13TEMAZEPAMORALCAPSULE007812201ANDA0714277c767b9f-5e02-475b-aaef-73944006e379
26675440038ANDAAphena Pharma Solutions - Tennessee, Inc.1988-01-12TEMAZEPAMORALCAPSULE007812201ANDA071427a2a65116-b351-4833-8813-c975161dad6a
27675440136ANDAAphena Pharma Solutions - Tennessee, Inc.1987-08-03TEMAZEPAMORALCAPSULE002282076ANDA0716382461dfbd-5704-42f4-bde7-d1461811d898
28675440217ANDAAphena Pharma Solutions - Tennessee, Inc.2012-10-25TEMAZEPAMORALCAPSULE003784010ANDA070920bd196d0b-9ab4-4ffc-9ca4-f0bf96f98715
29687889865ANDAPreferred Pharmaceuticals, Inc.2012-02-28TEMAZEPAMORALCAPSULE678770146ANDA07145668e2c1d8-9d6a-44a0-86f0-ba63a3263d22
30762370250ANDAMckesson Contract Packaging2011-12-06TEMAZEPAMORALCAPSULE007812201ANDA071427ce2748a3-72ab-407a-ac63-86ce1a126e18

temazepam 22.5 mg oral capsule

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004069959NDAMallinckrodt, Inc.2010-02-23TEMAZEPAMORALCAPSULENDA018163c9bc61b4-a579-4003-98da-b6f6e381c150

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003783120ANDAMylan Pharmaceuticals Inc.2009-06-15TEMAZEPAMORALCAPSULEANDA070920a5416154-8490-4e84-bb6f-4ff0cc605214
2006035893ANDAQualitest Pharmaceuticals2015-07-31TEMAZEPAMORALCAPSULEANDA201781471fa2f1-73a0-49be-89f3-d3e2cfdaeca0
3400320122ANDANovel Laboratories, Inc.2012-06-22TEMAZEPAMORALCAPSULEANDA07145785327378-86a3-4448-9185-e20bb20ebf45
4534890650ANDAMutual Pharmaceutical Company, Inc.2006-10-26TEMAZEPAMORALCAPSULEANDA0711753e4a35f8-77e5-4c9a-aad2-b0aeb98edd66
5678770149ANDAAscend Laboratories, Llc2012-06-28TEMAZEPAMORALCAPSULEANDA0714578f54731f-c5b7-492c-acb0-444c5fbb7029

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1353560821ANDALake Erie Medical Dba Quality Care Products Llc2012-06-28TEMAZEPAMORALCAPSULE678770149ANDA071457bcfd6a3d-66eb-4844-bede-6ec671985b2c
2504364630ANDAUnit Dose Services2012-06-28TEMAZEPAMORALCAPSULE678770149ANDA071457f1ff672d-0b95-4e1b-9104-a545e02f4ee7

temazepam 30 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004069917RestorilNDAMallinckrodt, Inc.2011-07-07TEMAZEPAMORALCAPSULENDA018163bc56f7fd-1aaf-48ff-8aa7-d467e59e1015

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1002282077ANDAActavis Elizabeth Llc1995-01-23TEMAZEPAMORALCAPSULEANDA071620a4370eb4-b00d-4247-af8d-980e59fbbec6
2003785050ANDAMylan Pharmaceuticals Inc.1986-07-10TEMAZEPAMORALCAPSULEANDA070920a5416154-8490-4e84-bb6f-4ff0cc605214
3006035894ANDAQualitest Pharmaceuticals2015-07-31TEMAZEPAMORALCAPSULEANDA201781471fa2f1-73a0-49be-89f3-d3e2cfdaeca0
4007812202ANDASandoz Inc1988-01-12TEMAZEPAMORALCAPSULEANDA071428fe3a8ab5-8603-4d8e-922c-7a41fbb815a5
5400320123ANDANovel Laboratories, Inc.2009-10-01TEMAZEPAMORALCAPSULEANDA07145785327378-86a3-4448-9185-e20bb20ebf45
6534890651ANDAMutual Pharmaceutical Company, Inc.2006-10-26TEMAZEPAMORALCAPSULEANDA0711753e4a35f8-77e5-4c9a-aad2-b0aeb98edd66
7678770147ANDAAscend Laboratories, Llc1987-04-21TEMAZEPAMORALCAPSULEANDA0714578f54731f-c5b7-492c-acb0-444c5fbb7029

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1006157809ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs1988-01-12TEMAZEPAMORALCAPSULE007812202ANDA07142870aaf6b1-91c9-4a5a-82c8-3c34c4e1dfe3
2216950283ANDARebel Distributors Corp1987-04-21TEMAZEPAMORALCAPSULE678770147ANDA07145709abc9b1-50fc-4c60-a6a1-9772e35b057a
3353560663ANDALake Erie Medical Dba Quality Care Products Llc1987-04-21TEMAZEPAMORALCAPSULE678770147ANDA071457bcfd6a3d-66eb-4844-bede-6ec671985b2c
4425490561ANDAStat Rx Usa Llc2010-05-24TEMAZEPAMORALCAPSULE003785050ANDA07092055f28be9-7d69-467c-b5de-6e281ca9c498
5499990346ANDALake Erie Medical Dba Quality Care Products Llc2012-02-14TEMAZEPAMORALCAPSULE003785050ANDA070920a2e1a7d2-aaba-45c7-9987-61f91e96f92c
6500900285ANDAA-S Medication Solutions Llc1987-04-21TEMAZEPAMORALCAPSULE678770147ANDA07145719b2711e-587a-47d2-ab62-d564e7b87195
7504364629ANDAUnit Dose Services1987-08-03TEMAZEPAMORALCAPSULE002282077ANDA071638becd63c1-5d14-4578-9f1e-df583f18a818
8510790419ANDAMylan Institutional Inc.1997-05-02TEMAZEPAMORALCAPSULE003785050ANDA070920a4a2e4e3-6213-4d72-bbdc-7c1447283e2b
9529590459ANDAH.J. Harkins Company, Inc.1987-04-21TEMAZEPAMORALCAPSULE678770147ANDA0714572ed81194-be24-45a0-8dde-fbc6ad3d7abe
10545691726ANDAA-S Medication Solutions Llc1987-04-21TEMAZEPAMORALCAPSULE678770147ANDA07145767040aa9-3a87-4c8a-882c-4b637a69d0b6
11548680039ANDAPhysicians Total Care, Inc.2005-01-11TEMAZEPAMORALCAPSULE003785050ANDA07092030dadf97-4e8c-4630-b362-940313a8852e
12551543446ANDACardinal Health1988-01-12TEMAZEPAMORALCAPSULE007812202ANDA0714282b673d8e-d16e-4a73-b7e3-0f1cc1f058df
13551545090ANDACardinal Health2011-02-04TEMAZEPAMORALCAPSULE510790419ANDA070920a4ee3907-45d4-41b9-af8a-39a9966cd533
14551546265ANDACardinal Health2012-10-25TEMAZEPAMORALCAPSULE003785050ANDA070920eeb9df6c-e8a7-470e-99d4-9c0495554720
15552890660ANDAPd-Rx Pharmaceuticals, Inc.1987-04-21TEMAZEPAMORALCAPSULE678770147ANDA07145762379cd5-a314-43eb-a1ee-33997623bfa3
16604290507ANDAGolden State Medical Supply, Inc.2014-01-10TEMAZEPAMORALCAPSULE002282077ANDA071620abdeee37-d0d8-4f22-a977-f8ea37c51f03
17619190264ANDADirect Rx2015-01-01TEMAZEPAMORALCAPSULE678770147ANDA07145709e74fd3-223b-4476-86b3-f5eeeb5af330
18619190438ANDADirect Rx2014-01-01TEMAZEPAMORALCAPSULE002282077ANDA0716205de3751c-66d8-4b77-8698-12b67aa5f9e8
19631870324ANDAProficient Rx Lp1986-07-10TEMAZEPAMORALCAPSULE003785050ANDA0709207df11f3e-f79b-4d52-a94b-4c0a31ebfe41
20631870497ANDAProficient Rx Lp1987-04-21TEMAZEPAMORALCAPSULE678770147ANDA0714575aaf8c99-cd58-47fc-8bf5-1039a6315ca5
21636291621ANDABryant Ranch Prepack1987-04-21TEMAZEPAMORALCAPSULE678770147ANDA07145719e1d930-20b3-81e3-0c6d-3e4979460444
22637390125ANDAMckesson Packaging Services A Business Unit Of Mckesson Corporation1987-04-21TEMAZEPAMORALCAPSULE678770147ANDA071457aeaa1606-a75f-44ad-99de-56567fcc40dc
23647252202ANDATya Pharmaceuticals1988-01-12TEMAZEPAMORALCAPSULE007812202ANDA071428b5b231ec-f5c4-4b2a-82f8-7b52396cb84f
24675440127ANDAAphena Pharma Solutions - Tennessee, Inc.2012-10-25TEMAZEPAMORALCAPSULE003785050ANDA070920bd196d0b-9ab4-4ffc-9ca4-f0bf96f98715
25675440287ANDAAphena Pharma Solutions - Tennessee, Inc.1987-08-03TEMAZEPAMORALCAPSULE002282077ANDA0716382461dfbd-5704-42f4-bde7-d1461811d898
26675440373ANDAAphena Pharma Solutions - Tennessee, Inc.1988-01-12TEMAZEPAMORALCAPSULE007812202ANDA071428a2a65116-b351-4833-8813-c975161dad6a
27680840910ANDAAmerican Health Packaging2015-03-31TEMAZEPAMORALCAPSULE678770147ANDA0714578d7dc0ae-303c-4ad3-9b76-42b5bafedb9d
28687889864ANDAPreferred Pharmaceuticals, Inc.2012-02-28TEMAZEPAMORALCAPSULE678770147ANDA07145768e2c1d8-9d6a-44a0-86f0-ba63a3263d22
29762370251ANDAMckesson Contract Packaging2011-11-21TEMAZEPAMORALCAPSULE007812202ANDA071428ce2748a3-72ab-407a-ac63-86ce1a126e18

temazepam 7.5 mg oral capsule

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004069960NDAMallinckrodt, Inc.2010-02-23TEMAZEPAMORALCAPSULENDA018163c9bc61b4-a579-4003-98da-b6f6e381c150

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003783110ANDAMylan Pharmaceuticals Inc.2010-05-18TEMAZEPAMORALCAPSULEANDA070920a5416154-8490-4e84-bb6f-4ff0cc605214
2006035891ANDAQualitest Pharmaceuticals2015-07-31TEMAZEPAMORALCAPSULEANDA201781471fa2f1-73a0-49be-89f3-d3e2cfdaeca0
3009046436ANDAMajor2015-03-25TEMAZEPAMORALCAPSULEANDA0714572c4f564d-d349-4f9b-b3f4-f3f0d9706a4d
4400320120ANDANovel Laboratories, Inc.2012-06-22TEMAZEPAMORALCAPSULEANDA07145785327378-86a3-4448-9185-e20bb20ebf45
5534890648ANDAMutual Pharmaceutical Company, Inc.2009-09-09TEMAZEPAMORALCAPSULEANDA0785813e4a35f8-77e5-4c9a-aad2-b0aeb98edd66
6678770148ANDAAscend Laboratories, Llc2012-06-28TEMAZEPAMORALCAPSULEANDA0714578f54731f-c5b7-492c-acb0-444c5fbb7029

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1001790045NDAKaiser Foundations Hospitals2010-03-23TEMAZEPAMORALCAPSULE004069960NDA01816389394e35-f134-4e47-91a5-0cbf14dbe793
2422910797ANDAAvkare, Inc.2015-08-25TEMAZEPAMORALCAPSULE534890648ANDA0785812fc457a3-2e5e-1e32-fe4d-ad00e15cf9e8
3433530711ANDAAphena Pharma Solutions - Tennessee, Llc2012-10-25TEMAZEPAMORALCAPSULE003783110ANDA0709204ac590e9-af71-43c0-a836-b700115d7ba2
4551547257RestorilNDACardinal Health2008-11-20TEMAZEPAMORALCAPSULE004069915NDA01816343fc3559-6482-4ff2-bd6a-40d881b3adb2
5637390003ANDAMckesson Packaging Services A Business Unit Of Mckesson Corporation1987-04-21TEMAZEPAMORALCAPSULE678770148ANDA071457aeaa1606-a75f-44ad-99de-56567fcc40dc
6680840549NDAAmerican Health Packaging2012-02-01TEMAZEPAMORALCAPSULE004069960NDA018163a3f06243-fa03-4cbd-951a-144ec43dcdfd

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA070383TEMAZEPAMTrueWATSON LABORATORIES INC1987-03-23ANDA070383_001
2ANDA070384TEMAZEPAMTrueWATSON LABORATORIES INC1987-03-23ANDA070384_001
3ANDA070489TEMAZEPAMTrueUSL PHARMA INC1986-07-07ANDA070489_001
4ANDA070490TEMAZEPAMTrueUSL PHARMA INC1986-07-07ANDA070490_001
5ANDA070547TEMAZTrueQUANTUM PHARMICS LTD1985-10-15ANDA070547_001
6ANDA070564TEMAZTrueQUANTUM PHARMICS LTD1985-10-15ANDA070564_001
7ANDA070920TEMAZEPAMMYLAN PHARMACEUTICALS INC1986-07-07ANDA070920_001, ANDA070920_002, ANDA070920_003, ANDA070920_004
8ANDA071174TEMAZEPAMTrueMUTUAL PHARMACEUTICAL CO INC1986-07-10ANDA071174_001
9ANDA071175TEMAZEPAMMUTUAL PHARMACEUTICAL CO INC1986-07-10ANDA071175_001, ANDA071175_002
10ANDA071427TEMAZEPAMSANDOZ INC1988-01-12ANDA071427_001
11ANDA071428TEMAZEPAMSANDOZ INC1988-01-12ANDA071428_001
12ANDA071446TEMAZEPAMTrueWATSON LABORATORIES INC1993-05-21ANDA071446_001
13ANDA071447TEMAZEPAMTrueWATSON LABORATORIES INC1993-05-21ANDA071447_001
14ANDA071456TEMAZEPAMNOVEL LABORATORIES INC1987-04-21ANDA071456_001
15ANDA071457TEMAZEPAMNOVEL LABORATORIES INC1987-04-21ANDA071457_001, ANDA071457_002, ANDA071457_003
16ANDA071620TEMAZEPAMACTAVIS ELIZABETH LLC1987-08-07ANDA071620_001
17ANDA071638TEMAZEPAMACTAVIS ELIZABETH LLC1987-08-07ANDA071638_001
18ANDA071708TEMAZEPAMTrueDURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INC1988-09-29ANDA071708_001
19ANDA071709TEMAZEPAMTrueDURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INC1988-09-29ANDA071709_001
20ANDA078581TEMAZEPAMMUTUAL PHARMACEUTICAL CO INC2009-09-08ANDA078581_001
21ANDA201781TEMAZEPAMVINTAGE PHARMACEUTICALS INC2015-06-04ANDA201781_001, ANDA201781_002, ANDA201781_003, ANDA201781_004
22NDA018163RESTORILMALLINCKRODT INCNDA018163_001, NDA018163_002, NDA018163_003, NDA018163_004

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA070383_001discontinuedTEMAZEPAM (15MG)ORALCAPSULEFalse1987-03-23TEMAZEPAM
2ANDA070384_001discontinuedTEMAZEPAM (30MG)ORALCAPSULEFalse1987-03-23TEMAZEPAM
3ANDA070489_001discontinuedTEMAZEPAM (15MG)ORALCAPSULEFalse1986-07-07TEMAZEPAM
4ANDA070490_001discontinuedTEMAZEPAM (30MG)ORALCAPSULEFalse1986-07-07TEMAZEPAM
5ANDA070547_001discontinuedTEMAZEPAM (30MG)ORALCAPSULEFalse1985-10-15TEMAZ
6ANDA070564_001discontinuedTEMAZEPAM (15MG)ORALCAPSULEFalse1985-10-15TEMAZ
7ANDA070920_001RXTEMAZEPAM (30MG)ORALCAPSULEFalseAB1986-07-10TEMAZEPAM
8ANDA070920_002RXTEMAZEPAM (7.5MG)ORALCAPSULEFalseAB2010-05-21TEMAZEPAM
9ANDA070920_003RXTEMAZEPAM (22.5MG)ORALCAPSULEFalseAB2009-06-12TEMAZEPAM
10ANDA070920_004RXTEMAZEPAM (15MG)ORALCAPSULEFalseAB1986-07-07TEMAZEPAM
11ANDA071174_001discontinuedTEMAZEPAM (15MG)ORALCAPSULEFalse1986-07-10TEMAZEPAM
12ANDA071175_001discontinuedTEMAZEPAM (30MG)ORALCAPSULEFalse1986-07-10TEMAZEPAM
13ANDA071175_002RXTEMAZEPAM (22.5MG)ORALCAPSULEFalseAB2009-09-14TEMAZEPAM
14ANDA071427_001RXTEMAZEPAM (15MG)ORALCAPSULEFalseAB1988-01-12TEMAZEPAM
15ANDA071428_001RXTEMAZEPAM (30MG)ORALCAPSULEFalseAB1988-01-12TEMAZEPAM
16ANDA071446_001discontinuedTEMAZEPAM (15MG)ORALCAPSULEFalse1993-05-21TEMAZEPAM
17ANDA071447_001discontinuedTEMAZEPAM (30MG)ORALCAPSULEFalse1993-05-21TEMAZEPAM
18ANDA071456_001RXTEMAZEPAM (15MG)ORALCAPSULEFalseAB1987-04-21TEMAZEPAM
19ANDA071457_001RXTEMAZEPAM (30MG)ORALCAPSULEFalseAB1987-04-21TEMAZEPAM
20ANDA071457_002RXTEMAZEPAM (7.5MG)ORALCAPSULEFalseAB2012-06-22TEMAZEPAM
21ANDA071457_003RXTEMAZEPAM (22.5MG)ORALCAPSULEFalseAB2012-06-22TEMAZEPAM
22ANDA071620_001RXTEMAZEPAM (30MG)ORALCAPSULEFalseAB1987-08-07TEMAZEPAM
23ANDA071638_001RXTEMAZEPAM (15MG)ORALCAPSULEFalseAB1987-08-07TEMAZEPAM
24ANDA071708_001discontinuedTEMAZEPAM (15MG)ORALCAPSULEFalse1988-09-29TEMAZEPAM
25ANDA071709_001discontinuedTEMAZEPAM (30MG)ORALCAPSULEFalse1988-09-29TEMAZEPAM
26ANDA078581_001RXTEMAZEPAM (7.5MG)ORALCAPSULEFalseAB2009-09-08TEMAZEPAM
27ANDA201781_001RXTEMAZEPAM (7.5MG)ORALCAPSULEFalseAB2015-06-04TEMAZEPAM
28ANDA201781_002RXTEMAZEPAM (15MG)ORALCAPSULEFalseAB2015-06-04TEMAZEPAM
29ANDA201781_003RXTEMAZEPAM (22.5MG)ORALCAPSULEFalseAB2015-06-04TEMAZEPAM
30ANDA201781_004RXTEMAZEPAM (30MG)ORALCAPSULEFalseAB2015-06-04TEMAZEPAM
31NDA018163_001RXTEMAZEPAM (15MG)ORALCAPSULEFalseABRESTORIL
32NDA018163_002RXTEMAZEPAM (30MG)ORALCAPSULETrueABRESTORIL
33NDA018163_003RXTEMAZEPAM (7.5MG)ORALCAPSULEFalseAB1991-10-25RESTORIL
34NDA018163_004RXTEMAZEPAM (22.5MG)ORALCAPSULEFalseAB2004-11-02RESTORIL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
109abc9b1-50fc-4c60-a6a1-9772e35b057a (view SPL)TemazepamprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-12-011216950283
209e74fd3-223b-4476-86b3-f5eeeb5af330 (view SPL)TEMAZEPAMprescriptionHuman PrescriptionDirect Rxrepack2015-10-261619190264
319b2711e-587a-47d2-ab62-d564e7b87195 (view SPL)prescriptionHuman PrescriptionA-S Medication Solutions Llcrepack2014-12-151500900186, 500900285
419e1d930-20b3-81e3-0c6d-3e4979460444 (view SPL)TEMAZEPAM Rx onlyprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK1987-04-212636291621
51c08d30d-7c27-a09a-5240-7050771d5cc7 (view SPL)TEMAZEPAM Rx onlyprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK1987-04-212636291619
62461dfbd-5704-42f4-bde7-d1461811d898 (view SPL)TEMAZEPAM CAPSULES, USP 40-8787 Revised - January 2009 Rx onlyprescriptionHuman PrescriptionAphena Pharma Solutions - Tennessee, Inc.Repack2013-05-021675440136, 675440287
72b673d8e-d16e-4a73-b7e3-0f1cc1f058df (view SPL)Temazepam Capsules, USP CIVprescriptionHuman PrescriptionCardinal HealthREPACK2011-05-171551543445, 551543446
82c4f564d-d349-4f9b-b3f4-f3f0d9706a4d (view SPL)Temazepam Capsules, USP Novel Laboratories, Inc. Rx onlyprescriptionHuman PrescriptionMajor2015-03-231009046436
92ed81194-be24-45a0-8dde-fbc6ad3d7abe (view SPL)prescriptionHuman PrescriptionH.J. Harkins Company, Inc.relabel, repack2012-04-194529590459, 529590535
102fc457a3-2e5e-1e32-fe4d-ad00e15cf9e8 (view SPL)TEMAZEPAM CAPSULES USP CIVprescriptionHuman PrescriptionAvkare, Inc.2015-08-251422910797
1130dadf97-4e8c-4630-b362-940313a8852e (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2009-09-044548680038, 548680039
123e4a35f8-77e5-4c9a-aad2-b0aeb98edd66 (view SPL)TEMAZEPAM CAPSULES USP CIVprescriptionHuman PrescriptionMutual Pharmaceutical Company, Inc.2014-07-316534890648, 534890649, 534890650, 534890651
1340b2ff05-3d35-4cd7-a525-0f8b507ac178 (view SPL)TEMAZEPAM CAPSULES, USP CIV Revised June 2012 Rx onlyprescriptionHuman PrescriptionKaiser Foundations Hospitalsrepack2014-04-221001791470
1443fc3559-6482-4ff2-bd6a-40d881b3adb2 (view SPL)Restoril (temazepam) Capsules USP CIV Rx onlyprescriptionHuman PrescriptionCardinal HealthREPACK2014-06-193551547257
15471fa2f1-73a0-49be-89f3-d3e2cfdaeca0 (view SPL)TEMAZEPAM CAPSULES USP CIV Rx onlyprescriptionHuman PrescriptionQualitest PharmaceuticalsMANUFACTURE2013-01-112006035891, 006035892, 006035893, 006035894
1647ff9717-042f-4df3-864e-3cd6ef19d33a (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2013-03-261521250198
174ac590e9-af71-43c0-a836-b700115d7ba2 (view SPL)prescriptionHuman PrescriptionAphena Pharma Solutions - Tennessee, LlcRepack2014-04-032433530711
1855f28be9-7d69-467c-b5de-6e281ca9c498 (view SPL)prescriptionHuman PrescriptionStat Rx Usa LlcRELABEL, REPACK2012-03-083425490561, 425490651
195aaf8c99-cd58-47fc-8bf5-1039a6315ca5 (view SPL)prescriptionHuman PrescriptionProficient Rx LpRELABEL, REPACK2015-02-011631870497
205da409a5-bb7b-4881-a3d7-044b4f75d6a0 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2014-03-191521250881
215de3751c-66d8-4b77-8698-12b67aa5f9e8 (view SPL)TEMAZEPAMprescriptionHuman PrescriptionDirect Rxrelabel, repack2014-04-031619190438
2262379cd5-a314-43eb-a1ee-33997623bfa3 (view SPL)prescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2011-03-057552890660
2367040aa9-3a87-4c8a-882c-4b637a69d0b6 (view SPL)prescriptionHuman PrescriptionA-S Medication Solutions Llcrepack2013-06-021545690905, 545691726
2468e2c1d8-9d6a-44a0-86f0-ba63a3263d22 (view SPL)prescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.RELABEL2013-07-102687889864, 687889865
256979644e-0587-4040-b754-5dce5eda87a4 (view SPL)TemazepamprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-12-011216950282
2670aaf6b1-91c9-4a5a-82c8-3c34c4e1dfe3 (view SPL)Temazepam Capsules, USP CIVprescriptionHuman PrescriptionNcs Healthcare Of Ky, Inc Dba Vangard LabsREPACK2015-07-071006157808, 006157809
2774f261c5-a960-44ef-be4c-4dcefd881c3f (view SPL)TEMAZEPAMprescriptionHuman PrescriptionDirect Rxrelabel, repack2014-04-021619190214
287c767b9f-5e02-475b-aaef-73944006e379 (view SPL)Temazepam Capsules, USP CIVprescriptionHuman PrescriptionMckesson Packaging Services A Business Unit Of Mckesson CorporationREPACK2014-02-052637390231
297df11f3e-f79b-4d52-a94b-4c0a31ebfe41 (view SPL)prescriptionHuman PrescriptionProficient Rx LpRELABEL, REPACK2014-03-271631870324
3085327378-86a3-4448-9185-e20bb20ebf45 (view SPL)Temazepam Capsules, USP Novel Laboratories, Inc. Rx onlyprescriptionHuman PrescriptionNovel Laboratories, Inc.ANALYSIS, MANUFACTURE2012-08-094400320120, 400320121, 400320122, 400320123
3189394e35-f134-4e47-91a5-0cbf14dbe793 (view SPL)Temazepam Capsules USP CIV Rx onlyprescriptionHuman PrescriptionKaiser Foundations Hospitalsmanufacture, repack2010-03-261001790045
328d7dc0ae-303c-4ad3-9b76-42b5bafedb9d (view SPL)Temazepam Capsules, USP CIV(temazepam)prescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-03-051680840910
338f54731f-c5b7-492c-acb0-444c5fbb7029 (view SPL)prescriptionHuman PrescriptionAscend Laboratories, Llc2015-01-1510678770146, 678770147, 678770148, 678770149
34904b8986-24da-48eb-bb0a-33d41b4eb005 (view SPL)prescriptionHuman PrescriptionProficient Rx LpRELABEL, REPACK2014-07-011631870132
35a2a65116-b351-4833-8813-c975161dad6a (view SPL)Temazepam Capsules, USP CIVprescriptionHuman PrescriptionAphena Pharma Solutions - Tennessee, Inc.Repack2013-05-132675440038, 675440373
36a2e1a7d2-aaba-45c7-9987-61f91e96f92c (view SPL)prescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products LlcANALYSIS, MANUFACTURE, relabel, repack2012-02-143561499990346
37a3f06243-fa03-4cbd-951a-144ec43dcdfd (view SPL)Temazepam Capsules USP C-IVprescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-10-073680840549
38a4370eb4-b00d-4247-af8d-980e59fbbec6 (view SPL)TEMAZEPAM CAPSULES, USP CIV 40-9177 Revised June 2012 Rx onlyprescriptionHuman PrescriptionActavis Elizabeth LlcANALYSIS, MANUFACTURE, PACK2013-07-085002282076, 002282077
39a4a2e4e3-6213-4d72-bbdc-7c1447283e2b (view SPL)prescriptionHuman PrescriptionMylan Institutional Inc.2012-10-052510790418, 510790419
40a4ee3907-45d4-41b9-af8a-39a9966cd533 (view SPL)prescriptionHuman PrescriptionCardinal HealthREPACK2015-03-237551545090, 551545591
41a5416154-8490-4e84-bb6f-4ff0cc605214 (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2015-08-2410003783110, 003783120, 003784010, 003785050
42abdeee37-d0d8-4f22-a977-f8ea37c51f03 (view SPL)TEMAZEPAM CAPSULES, USP, CIV 40-9177 Revised June 2012 Rx onlyprescriptionHuman PrescriptionGolden State Medical Supply, Inc.RELABEL, REPACK2012-12-311604290506, 604290507
43aeaa1606-a75f-44ad-99de-56567fcc40dc (view SPL)prescriptionHuman PrescriptionMckesson Packaging Services A Business Unit Of Mckesson CorporationREPACK2015-11-021637390003, 637390125
44b5b231ec-f5c4-4b2a-82f8-7b52396cb84f (view SPL)Temazepam Capsules, USP CIVprescriptionHuman PrescriptionTya PharmaceuticalsRELABEL, REPACK2011-10-212647252202
45b9d4ff6b-4e36-4530-8b67-4403ed2d357e (view SPL)prescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products LlcANALYSIS, MANUFACTURE, repack2011-12-283429499990045
46bc56f7fd-1aaf-48ff-8aa7-d467e59e1015 (view SPL)Restoril (temazepam) Capsules USP CIV Rx onlyprescriptionHuman PrescriptionMallinckrodt, Inc.ANALYSIS, MANUFACTURE2014-11-308004069916, 004069917, 004069914, 004069915
47bcfd6a3d-66eb-4844-bede-6ec671985b2c (view SPL)prescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrepack2013-06-133945353560663, 353560664, 353560821
48bd196d0b-9ab4-4ffc-9ca4-f0bf96f98715 (view SPL)prescriptionHuman PrescriptionAphena Pharma Solutions - Tennessee, Inc.Repack2014-06-052675440127, 675440217
49becd63c1-5d14-4578-9f1e-df583f18a818 (view SPL)40-8787 Revised - January 2009 TEMAZEPAM CAPSULES, USP Rx onlyprescriptionHuman PrescriptionUnit Dose ServicesREPACK2008-01-013504364629
50c270129a-03e8-4c3d-a47e-0e533f05b2ad (view SPL)TEMAZEPAM CAPSULES, USP CIV 40-9177 Revised June 2012 Rx onlyprescriptionHuman PrescriptionRxchange Co.manufacture2014-12-012333580332
51c9bc61b4-a579-4003-98da-b6f6e381c150 (view SPL)TemazepamCapsules USP CIV Rx onlyprescriptionHuman PrescriptionMallinckrodt, Inc.ANALYSIS, MANUFACTURE2014-11-305004069959, 004069960
52ce2748a3-72ab-407a-ac63-86ce1a126e18 (view SPL)Temazepam Capsules, USP CIVprescriptionHuman PrescriptionMckesson Contract PackagingREPACK2012-09-132762370250, 762370251
53dbd39517-62f5-44b0-844f-e1cbf3c6ca2e (view SPL)40-8787 Revised - January 2009 TEMAZEPAM CAPSULES, USP Rx onlyprescriptionHuman PrescriptionUnit Dose ServicesREPACK2008-01-015504364628
54eeb9df6c-e8a7-470e-99d4-9c0495554720 (view SPL)prescriptionHuman PrescriptionCardinal HealthREPACK2015-04-308551546264, 551546265
55f0f4184e-e7e1-49e6-9b93-ac599ac524c6 (view SPL)TEMAZEPAM CAPSULES, USP CIVprescriptionHuman PrescriptionStat Rx Usa Llcrelabel, repack2012-08-201165900214
56f1ff672d-0b95-4e1b-9104-a545e02f4ee7 (view SPL)prescriptionHuman PrescriptionUnit Dose ServicesREPACK2013-02-143504364630
57f7c31cab-c96b-45e1-8c29-48e17b3fd731 (view SPL)TEMAZEPAMprescriptionHuman PrescriptionDirect Rxrepack2015-10-271619190263
58fe3a8ab5-8603-4d8e-922c-7a41fbb815a5 (view SPL)Temazepam Capsules, USP CIVprescriptionHuman PrescriptionSandoz Inc2011-10-2111007812201, 007812202

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