Nevirapine Extended Release Oral Tablet

Brand(s)
Viramune
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Boehringer Ingelheim Pharmaceuticals, Inc. (2014-09-11)
Oldest Current Product
2011-04-11
License(s)
NDA, ANDA
RxNORM
EXTENDED RELEASE ORAL TABLET\NEVIRAPINE
FDAOB
ORAL\TABLET, EXTENDED RELEASE\NEVIRAPINE
SPL Active
ORAL\TABLET, EXTENDED RELEASE\NEVIRAPINE
ORAL\TABLET\NEVIRAPINE
SPL Moiety
ORAL\TABLET, EXTENDED RELEASE\NEVIRAPINE
ORAL\TABLET\NEVIRAPINE

product(s) by strength(s)

24 hr nevirapine 100 mg extended release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005970129ViramuneNDABoehringer Ingelheim Pharmaceuticals, Inc.2013-03-01NEVIRAPINEORALTABLET, EXTENDED RELEASENDA20115282598cb3-a0eb-4ff2-8b8d-d8da96c25388

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003786950ANDAMylan Pharmaceuticals Inc.2015-11-09NEVIRAPINEORALTABLET, EXTENDED RELEASEANDA2062719e52bd5c-c706-4e2f-98c1-d04e2bb2284a

24 hr nevirapine 400 mg extended release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005970123ViramuneNDABoehringer Ingelheim Pharmaceuticals, Inc.2011-04-11NEVIRAPINEORALTABLET, EXTENDED RELEASENDA20115282598cb3-a0eb-4ff2-8b8d-d8da96c25388

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003784890ANDAMylan Pharmaceuticals Inc.2014-10-29NEVIRAPINEORALTABLET, EXTENDED RELEASEANDA205651690da74b-2481-47fc-93ae-8340e0caf0a4
2007815893ANDASandoz Inc2014-04-15NEVIRAPINEORALTABLET, EXTENDED RELEASEANDA20341124fd285a-bec3-41b5-9026-b263da83c54f
3477810317ANDAAlvogen, Inc.2015-07-14NEVIRAPINEORALTABLETANDA204621af5e4797-ac41-98f3-64eb-d8def4a104fe
4605054058ANDAApotex Corp2014-04-15NEVIRAPINEORALTABLET, EXTENDED RELEASEANDA205258a665d4a3-415f-e168-2745-b32ac05f2234

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548686370ViramuneNDAPhysicians Total Care, Inc.2013-01-23NEVIRAPINEORALTABLET, EXTENDED RELEASE005970123NDA20115209f08fe4-69ee-4f03-8663-62aa76b3ad97

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1ANDA203411NEVIRAPINESANDOZ INC2014-04-03PATENT CHALLENGE [2014-10-12]ANDA203411_001
2ANDA204621NEVIRAPINEALVOGEN MALTA OPERATIONS LTD2015-07-10ANDA204621_001, ANDA204621_002
3ANDA205258NEVIRAPINEAPOTEX INC2014-04-03PATENT CHALLENGE [2014-10-12]ANDA205258_001
4ANDA205651NEVIRAPINEMYLAN PHARMACEUTICALS INC2014-10-27ANDA205651_001
5ANDA206271NEVIRAPINEMYLAN PHARMACEUTICALS INC2015-11-09ANDA206271_001
6ANDA206448NEVIRAPINECIPLA LTD2015-10-15ANDA206448_001
7NDA201152VIRAMUNE XRBOEHRINGER INGELHEIM PHARMACEUTICALS INC2011-03-25p8460704, TREATMENT OF HIV-1 BY ONCE DAILY ADMINISTRATIONNEW PATIENT POPULATION [2015-11-08]NDA201152_001, NDA201152_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA203411_001RXNEVIRAPINE (400MG)ORALTABLET, EXTENDED RELEASEFalseAB2014-04-03NEVIRAPINE
2ANDA204621_001RXNEVIRAPINE (400MG)ORALTABLET, EXTENDED RELEASEFalseAB2015-07-10NEVIRAPINE
3ANDA204621_002RXNEVIRAPINE (100MG)ORALTABLET, EXTENDED RELEASEFalseAB2015-11-09NEVIRAPINE
4ANDA205258_001RXNEVIRAPINE (400MG)ORALTABLET, EXTENDED RELEASEFalseAB2014-04-03NEVIRAPINE
5ANDA205651_001RXNEVIRAPINE (400MG)ORALTABLET, EXTENDED RELEASEFalseAB2014-10-27NEVIRAPINE
6ANDA206271_001RXNEVIRAPINE (100MG)ORALTABLET, EXTENDED RELEASEFalseAB2015-11-09NEVIRAPINE
7ANDA206448_001RXNEVIRAPINE (400MG)ORALTABLET, EXTENDED RELEASEFalseAB2015-10-15NEVIRAPINE
8NDA201152_001RXNEVIRAPINE (400MG)ORALTABLET, EXTENDED RELEASETrueAB2011-03-25VIRAMUNE XR
9NDA201152_002RXNEVIRAPINE (100MG)ORALTABLET, EXTENDED RELEASEFalseAB2012-11-08VIRAMUNE XR

patent(s)

#idexpiration dateapplication(s)
1p8460704 (view patent)2029-03-12NDA201152

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
109f08fe4-69ee-4f03-8663-62aa76b3ad97 (view SPL)These highlights do not include all the information needed to use VIRAMUNE XR safely and effectively. See full prescribing information for VIRAMUNE XR. Viramune XR (nevirapine) Extended-Release Tablets, for oral useInitial U.S. Approval: 1996prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2013-02-061548686370
224fd285a-bec3-41b5-9026-b263da83c54f (view SPL)These highlights do not include all the information needed to use NEVIRAPINE extended-release tablets safely and effectively. See full prescribing information for NEVIRAPINE extended-release tablets. NEVIRAPINE extended-release tablets, for oral useInitial U.S. Approval: 1996prescriptionHuman PrescriptionSandoz Inc2015-03-2313007815893
3690da74b-2481-47fc-93ae-8340e0caf0a4 (view SPL)These highlights do not include all the information needed to use nevirapine extended-release tablets safely and effectively. See full prescribing information for nevirapine extended-release tablets. NEVIRAPINE extended-release tablets, for oral use Initial U.S. Approval: 1996prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2014-07-101003784890
482598cb3-a0eb-4ff2-8b8d-d8da96c25388 (view SPL)These highlights do not include all the information needed to use VIRAMUNE XR safely and effectively. See full prescribing information for VIRAMUNE XR. VIRAMUNE XR (nevirapine) extended-release tablets, for oral useInitial U.S. Approval: 1996prescriptionHuman PrescriptionBoehringer Ingelheim Pharmaceuticals, Inc.ANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2014-09-119005970123, 005970129
59e52bd5c-c706-4e2f-98c1-d04e2bb2284a (view SPL)These highlights do not include all the information needed to use nevirapine extended-release tablets safely and effectively. See full prescribing information for nevirapine extended-release tablets. NEVIRAPINE extended-release tablets, for oral use Initial U.S. Approval: 1996prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2015-05-193003786950
6a665d4a3-415f-e168-2745-b32ac05f2234 (view SPL)These highlights do not include all the information needed to use nevirapine extended-release tablet safely and effectively. See full prescribing information for nevirapine extended-release tablet. NEVIRAPINE extended-release tablets, for oral useInitial U.S. Approval: 1996prescriptionHuman PrescriptionApotex Corpanalysis, manufacture2014-04-022605054058
7af5e4797-ac41-98f3-64eb-d8def4a104fe (view SPL)These highlights do not include all the information needed to use Nevirapine Extended Release Tablets safely and effectively. See full prescribing information for Nevirapine Extended Release Tablets. NEVIRAPINE extended-release tablets , for oral use Initial U.S. Approval: 1996prescriptionHuman PrescriptionAlvogen, Inc.analysis, manufacture, pack2013-10-097477810317

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