Nevirapine Oral Tablet

Brand(s)
Viramune
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Boehringer Ingelheim Pharmaceuticals, Inc. (2014-01-31)
Oldest Current Product
2001-08-01
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL TABLET\NEVIRAPINE
FDAOB
ORAL\TABLET\NEVIRAPINE
SPL Active
ORAL\TABLET\NEVIRAPINE
SPL Moiety
ORAL\TABLET\NEVIRAPINE

product(s) by strength(s)

nevirapine 200 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005970046ViramuneNDABoehringer Ingelheim Pharmaceuticals, Inc.2001-08-01NEVIRAPINEORALTABLETNDA0206365ec05500-6333-4bd0-ac83-464fad0d5162

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540459NDA AUTHORIZED GENERICRoxane Laboratories, Inc2012-05-21NEVIRAPINEORALTABLETNDA020636645607af-3ef3-4765-bbff-ba9c483be141
2003784050ANDAMylan Pharmaceuticals Inc.2012-05-22NEVIRAPINEORALTABLETANDA202523c6e93829-7024-48f6-8023-da6ff27dfc0a
3317220505ANDACamber Pharmaceuticals, Inc.2012-05-23NEVIRAPINEORALTABLETANDA07858461409678-d2f6-42cd-b03d-b26b11b39641
4477810100ANDAAlvogen, Inc.2012-05-22NEVIRAPINEORALTABLETANDA2031765d5d8d1c-f418-455a-c693-c82a79df3637
5519910331ANDABreckenridge Pharmaceutical, Inc.2011-04-11NEVIRAPINEORALTABLETANDA078644b3e740ad-46d9-48f5-85ab-7c319919ceb1
6531040166ANDACipla Ltd.2012-05-22NEVIRAPINEORALTABLETANDA0779564d056e75-6122-4733-96cc-b21c7c944192
7531500209ANDAAmneal-Agila, Llc2014-04-30NEVIRAPINEORALTABLETANDA078195c0e857ce-6557-413d-9b81-9991ae1ef52a
8604290298ANDAGolden State Medical Supply, Inc.2012-05-22NEVIRAPINEORALTABLETANDA20317664392954-0d2d-4946-bb5c-05d4b81dc319
9605053788ANDAApotex Corp2012-05-22NEVIRAPINEORALTABLETANDA203021b8d95ad1-4725-fec7-e7e2-062cbb46d873
10651620209ANDAAmneal Pharmaceuticals2014-04-30NEVIRAPINEORALTABLETANDA0781954f065674-4719-4c79-ba0d-549040d77f17
11658620027ANDAAurobindo Pharma Limited2012-05-22NEVIRAPINEORALTABLETANDA0775215f6c3eed-2a5d-46ed-9a7c-59715f338a15

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1538080680ANDAState Of Florida Doh Central Pharmacy2013-01-01NEVIRAPINEORALTABLET003784050ANDA202523e6267bd6-dd60-48d7-969c-c3ebaf113eb7
2538080808ViramuneNDAState Of Florida Doh Central Pharmacy2009-07-01NEVIRAPINEORALTABLET005970046NDA02063646fb9dbc-5345-48a4-a0ec-75039622c76c
3538081069ANDAState Of Florida Doh Central Pharmacy2014-11-01NEVIRAPINEORALTABLET477810100ANDA203176ea81309d-c41e-404a-8ad2-f232c4587a87

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA077521NEVIRAPINEAUROBINDO PHARMA LTD2012-05-22ANDA077521_001
2ANDA077956NEVIRAPINECIPLA LTD2012-05-22ANDA077956_001
3ANDA078195NEVIRAPINESTRIDES PHARMA GLOBAL PTE LTD2012-05-22ANDA078195_001
4ANDA078584NEVIRAPINEHETERO LABS LTD UNIT III2012-05-22ANDA078584_001
5ANDA078644NEVIRAPINEPRINSTON PHARMACEUTICAL INC2012-05-22ANDA078644_001
6ANDA078864NEVIRAPINEMYLAN LABORATORIES LTD2012-05-22ANDA078864_001
7ANDA202523NEVIRAPINEMYLAN PHARMACEUTICALS INC2012-05-22ANDA202523_001
8ANDA203021NEVIRAPINEAPOTEX INC2012-05-22ANDA203021_001
9ANDA203080NEVIRAPINEMICRO LABS LTD2012-05-22ANDA203080_001
10ANDA203176NEVIRAPINESCIEGEN PHARMACEUTICALS INC2012-05-22ANDA203176_001
11NDA020636VIRAMUNEBOEHRINGER INGELHEIM PHARMACEUTICALS INC1996-06-21NDA020636_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA077521_001RXNEVIRAPINE (200MG)ORALTABLETFalseAB2012-05-22NEVIRAPINE
2ANDA077956_001RXNEVIRAPINE (200MG)ORALTABLETFalseAB2012-05-22NEVIRAPINE
3ANDA078195_001RXNEVIRAPINE (200MG)ORALTABLETFalseAB2012-05-22NEVIRAPINE
4ANDA078584_001RXNEVIRAPINE (200MG)ORALTABLETFalseAB2012-05-22NEVIRAPINE
5ANDA078644_001RXNEVIRAPINE (200MG)ORALTABLETFalseAB2012-05-22NEVIRAPINE
6ANDA078864_001RXNEVIRAPINE (200MG)ORALTABLETFalseAB2012-05-22NEVIRAPINE
7ANDA202523_001RXNEVIRAPINE (200MG)ORALTABLETFalseAB2012-05-22NEVIRAPINE
8ANDA203021_001RXNEVIRAPINE (200MG)ORALTABLETFalseAB2012-05-22NEVIRAPINE
9ANDA203080_001RXNEVIRAPINE (200MG)ORALTABLETFalseAB2012-05-22NEVIRAPINE
10ANDA203176_001RXNEVIRAPINE (200MG)ORALTABLETFalseAB2012-05-22NEVIRAPINE
11NDA020636_001RXNEVIRAPINE (200MG)ORALTABLETTrueAB1996-06-21VIRAMUNE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
146fb9dbc-5345-48a4-a0ec-75039622c76c (view SPL)These highlights do not include all the information needed to use VIRAMUNE safely and effectively. See full prescribing information for VIRAMUNE. Viramune (nevirapine) tablets 200 mg Viramune (nevirapine) oral suspension 50 mg/5 mL Initial U.S. Approval: 1996prescriptionHuman PrescriptionState Of Florida Doh Central Pharmacyrepack2010-05-211538080808
24d056e75-6122-4733-96cc-b21c7c944192 (view SPL)These highlights do not include all the information needed to use Nevirapine safely and effectively. See full prescribing information for Nevirapine. NEVIRAPINE Tablets USP, 200 mg, for oral use Initial U.S. Approval: 1996prescriptionHuman PrescriptionCipla Ltd.Manufacture2014-10-282531040166
34f065674-4719-4c79-ba0d-549040d77f17 (view SPL)These highlights do not include all the information needed to useNevirapine safely and effectively. See full prescribing information for Nevirapine. Nevirapine Tablets, USP 200 mgfororal use Initial U.S. Approval: 1996prescriptionHuman PrescriptionAmneal PharmaceuticalsANALYSIS, MANUFACTURE, PACK2011-11-304651620209
45d5d8d1c-f418-455a-c693-c82a79df3637 (view SPL)These highlights do not include all the information needed to use nevirapine tablets, USP safely and effectively. See full prescribing information for nevirapine tablets, USP. Nevirapine tablets, USP 200 mg, for oral useInitial U.S. Approval: 1996prescriptionHuman PrescriptionAlvogen, Inc.analysis, manufacture2013-05-145477810100
55ec05500-6333-4bd0-ac83-464fad0d5162 (view SPL)These highlights do not include all the information needed to use VIRAMUNE safely and effectively. See full prescribing information for VIRAMUNE.VIRAMUNE (nevirapine) tablets, for oral useVIRAMUNE (nevirapine) oral suspension, for oral useInitial U.S. Approval: 1996prescriptionHuman PrescriptionBoehringer Ingelheim Pharmaceuticals, Inc.ANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2014-01-3113005970046, 005970047Nevirapine Oral Suspension
65f6c3eed-2a5d-46ed-9a7c-59715f338a15 (view SPL)These highlights do not include all the information needed to use nevirapine tablets, USP safely and effectively. See full prescribing information for nevirapine tablets, USP. NEVIRAPINE Tablets USP, for oral useInitial U.S. Approval: 1996prescriptionHuman PrescriptionAurobindo Pharma LimitedANALYSIS, API MANUFACTURE, MANUFACTURE2014-02-284658620027
761409678-d2f6-42cd-b03d-b26b11b39641 (view SPL)These highlights do not include all the information needed to use nevirapine safely and effectively. See full prescribing information for nevirapine.NEVIRAPINE tablets, USP for oral use.Initial U.S. Approval: 1996prescriptionHuman PrescriptionCamber Pharmaceuticals, Inc.ANALYSIS, MANUFACTURE2015-05-158317220505
864392954-0d2d-4946-bb5c-05d4b81dc319 (view SPL)HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use nevirapine safely and effectively. See full prescribing information for nevirapine.Nevirapine, USP tablets 200 mgInitial U.S. Approval: 1996prescriptionHuman PrescriptionGolden State Medical Supply, Inc.MANUFACTURE, RELABEL, REPACK2013-01-033604290298
9645607af-3ef3-4765-bbff-ba9c483be141 (view SPL)These highlights do not include all the information needed to use NEVIRAPINE tablets and oral suspension safely and effectively. See full prescribing information for NEVIRAPINE tablets and oral suspension.NEVIRAPINE tablets, for oral useNEVIRAPINE oral suspension, for oral useInitial U.S. Approval: 1996prescriptionHuman PrescriptionRoxane Laboratories, IncANALYSIS, LABEL, MANUFACTURE, PACK2014-04-012000540459, 000540450Nevirapine Oral Suspension
10b3e740ad-46d9-48f5-85ab-7c319919ceb1 (view SPL)These highlights do not include all the information needed to use Nevirapine safely and effectively. See full prescribing information for Nevirapine.NEVIRAPINE tablets USP, for oral useInitial U.S. Approval: 1996prescriptionHuman PrescriptionBreckenridge Pharmaceutical, Inc.MANUFACTURE2015-03-126519910331
11b8d95ad1-4725-fec7-e7e2-062cbb46d873 (view SPL)These highlights do not include all the information needed to use nevirapine tablets, USP safely and effectively. See full prescribing information for nevirapine tablets, USP. NEVIRAPINE Tablets, USP for oral use Initial U.S. Approval: 1996prescriptionHuman PrescriptionApotex Corpanalysis, manufacture2014-03-314605053788
12c0e857ce-6557-413d-9b81-9991ae1ef52a (view SPL)These highlights do not include all the information needed to useNevirapine safely and effectively. See full prescribing information for Nevirapine. Nevirapine Tablets, USP 200 mgfororal use Initial U.S. Approval: 1996prescriptionHuman PrescriptionAmneal-Agila, LlcANALYSIS, MANUFACTURE, PACK2011-11-301531500209
13c6e93829-7024-48f6-8023-da6ff27dfc0a (view SPL)These highlights do not include all the information needed to use nevirapine tablets safely and effectively. See full prescribing information for nevirapine tablets.Nevirapine Tablets USP, 200 mg Initial U.S. Approval: 1996prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2012-01-114003784050
14e6267bd6-dd60-48d7-969c-c3ebaf113eb7 (view SPL)These highlights do not include all the information needed to use nevirapine tablets safely and effectively. See full prescribing information for nevirapine tablets.Nevirapine Tablets USP, 200 mg Initial U.S. Approval: 1996prescriptionHuman PrescriptionState Of Florida Doh Central Pharmacyrepack2013-09-261538080680
15ea81309d-c41e-404a-8ad2-f232c4587a87 (view SPL)These highlights do not include all the information needed to use nevirapine tablets, USP safely and effectively. See full prescribing information for nevirapine tablets, USP. Nevirapine tablets, USP 200 mg, for oral useInitial U.S. Approval: 1996prescriptionHuman PrescriptionState Of Florida Doh Central Pharmacyrepack2015-01-101538081069

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