FDA.reportPublic FDA data

Application 020933

Type
NDA
Sponsor
BOEHRINGER INGELHEIM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VIRAMUNENEVIRAPINESUSPENSION;ORAL50MG/5MLYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020933-001VIRAMUNENEVIRAPINE50MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SUSPENSION / ORALRLD1998-09-11

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N020933-001VIRAMUNE50MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SUSPENSION / ORALRLD1998-09-11a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NEVIRAPINENEVIRAPINEMicro Labs Limitedfbd628db-4076-4fe0-8323-9cc33ae92e422025-10-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: NEVIRAPINE
NevirapineNEVIRAPINEMylan Pharmaceuticals Inc.690da74b-2481-47fc-93ae-8340e0caf0a42024-10-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: NEVIRAPINE
NevirapineNEVIRAPINEAurobindo Pharma Limited8dfe86aa-ea5d-48d2-94a8-1a5506055d702024-09-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: NEVIRAPINE
NEVIRAPINENEVIRAPINEMacleods Pharmaceuticals Limited2620b114-f53f-44f1-8708-697e863430902024-08-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: NEVIRAPINE
NevirapineNEVIRAPINEAurobindo Pharma Limited5f6c3eed-2a5d-46ed-9a7c-59715f338a152024-05-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: NEVIRAPINE
NevirapineNEVIRAPINEMylan Pharmaceuticals Inc.c6e93829-7024-48f6-8023-da6ff27dfc0a2024-01-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: NEVIRAPINE
NevirapineNEVIRAPINEMacleods Pharmaceuticals Limitedeffb86cc-4b80-4fac-aaa3-9f373b3d0f7d2023-08-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: NEVIRAPINE
NevirapineNEVIRAPINECamber Pharmaceuticals, Inc.61409678-d2f6-42cd-b03d-b26b11b396412022-08-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: NEVIRAPINE
NevirapineNEVIRAPINEAmneal Pharmaceuticals LLC4f065674-4719-4c79-ba0d-549040d77f172012-08-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: NEVIRAPINE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0597-0047ViramunenevirapineBoehringer Ingelheim Pharmaceuticals Inc.NDACurrent
0597-0047ViramunenevirapineBoehringer Ingelheim Pharmaceuticals Inc.NDACurrent
0597-0047ViramunenevirapineBoehringer Ingelheim Pharmaceuticals Inc.NDACurrent
0597-0047ViramunenevirapineBoehringer Ingelheim Pharmaceuticals Inc.NDACurrent
0597-0047ViramunenevirapineBoehringer Ingelheim Pharmaceuticals Inc.NDACurrent
0597-0047ViramunenevirapineBoehringer Ingelheim Pharmaceuticals Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79167SUPPL 2024-07-24
79165SUPPL 2024-07-24
79149SUPPL 2024-07-23
71317SUPPL2022-06-15
71316SUPPL2022-06-15
71285SUPPL2022-06-13
55743SUPPL2018-10-01
55614SUPPL2018-09-25
55612SUPPL2018-09-25
47767SUPPL2017-03-29
47737SUPPL2017-03-28
35662SUPPL2014-01-28
26225SUPPL2014-01-28
13766SUPPL2012-11-15
26224SUPPL2012-11-13
26223SUPPL2011-11-14
13765SUPPL2011-11-10
26222SUPPL2011-05-10
3783SUPPL2011-03-31
13764SUPPL2011-03-28
26221SUPPL2011-01-14
35661SUPPL2011-01-10
3782SUPPL2010-07-23
35660SUPPL2010-07-22
3781SUPPL2010-01-26
13763SUPPL2010-01-20
3779SUPPL2008-06-30
13761SUPPL2008-06-26
13762SUPPL2007-08-17
3780SUPPL2007-08-17
21282SUPPL2007-07-27
13760SUPPL2007-04-20
3778SUPPL2007-04-20
41820SUPPL2005-04-27
35659SUPPL2005-03-02
3777SUPPL2005-03-02
26219SUPPL2004-06-30
13756ORIG2004-06-30
3775SUPPL2004-06-30
3774ORIG2004-06-30
41819ORIG2004-02-09
13759SUPPL2003-12-29
26220SUPPL2003-12-23
13758SUPPL2003-08-06
13757SUPPL2003-04-04
3776SUPPL2002-03-27