Nevirapine Oral Suspension

Brand(s)
Viramune
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Boehringer Ingelheim Pharmaceuticals, Inc. (2014-01-31)
Oldest Current Product
2001-10-01
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL SUSPENSION\NEVIRAPINE
FDAOB
ORAL\SUSPENSION\NEVIRAPINE
SPL Active
ORAL\SUSPENSION\NEVIRAPINE
ORAL\SUSPENSION\NEVIRAPINE HEMIHYDRATE
SPL Moiety
ORAL\SUSPENSION\NEVIRAPINE

product(s) by strength(s)

nevirapine 10 mg/ml oral suspension

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005970047ViramuneNDABoehringer Ingelheim Pharmaceuticals, Inc.2001-10-01NEVIRAPINEORALSUSPENSIONNDA0209335ec05500-6333-4bd0-ac83-464fad0d5162

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540450NDA AUTHORIZED GENERICRoxane Laboratories, Inc2012-05-21NEVIRAPINEORALSUSPENSIONNDA020933645607af-3ef3-4765-bbff-ba9c483be141
2658620057ANDAAurobindo Pharma Limited2012-05-22NEVIRAPINE HEMIHYDRATEORALSUSPENSIONANDA0777028dfe86aa-ea5d-48d2-94a8-1a5506055d70

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA077702NEVIRAPINEAUROBINDO PHARMA LTD2012-05-22ANDA077702_001
2NDA020933VIRAMUNEBOEHRINGER INGELHEIM PHARMACEUTICALS INC1998-09-11NDA020933_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA077702_001RXNEVIRAPINE (50MG/5ML)ORALSUSPENSIONFalseAA2012-05-22NEVIRAPINE
2NDA020933_001RXNEVIRAPINE (50MG/5ML)ORALSUSPENSIONTrueAA1998-09-11VIRAMUNE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
15ec05500-6333-4bd0-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, PACK2014-01-3113005970047, 005970046Nevirapine Oral Tablet
2645607af-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, PACK2014-04-012000540450, 000540459Nevirapine Oral Tablet
38dfe86aa-ea5d-48d2-94a8-1a5506055d70 (view SPL)These highlights do not include all the information needed to use nevirapine safely and effectively. See full prescribing information for nevirapine oral suspension, USP. NEVIRAPINE oral suspension USP, for oral useInitial U.S. Approval: 1996prescriptionHuman PrescriptionAurobindo Pharma LimitedANALYSIS, API MANUFACTURE, MANUFACTURE2015-04-284658620057

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