FDA.reportPublic FDA data

Application 020636

Type
NDA
Sponsor
BOEHRINGER INGELHEIM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VIRAMUNENEVIRAPINETABLET;ORAL200MGYesYes

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
N020636-001VIRAMUNENEVIRAPINE200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1996-06-21

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 22:54:322026-06N020636-001VIRAMUNE200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1996-06-21a50c72e98297…

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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0597-0046ViramunenevirapineBoehringer Ingelheim Pharmaceuticals Inc.NDACurrent
0597-0046ViramunenevirapineBoehringer Ingelheim Pharmaceuticals Inc.NDACurrent
0597-0046ViramunenevirapineBoehringer Ingelheim Pharmaceuticals Inc.NDACurrent
53808-0808ViramunenevirapineState of Florida DOH Central PharmacyNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
71313SUPPL2022-06-15
71312SUPPL2022-06-15
71284SUPPL2022-06-13
57682ORIG2019-02-15
55742SUPPL2018-10-01
55615SUPPL2018-09-25
55613SUPPL2018-09-25
47768SUPPL2017-03-29
47735SUPPL2017-03-28
25413SUPPL2014-01-28
12906SUPPL2014-01-28
35050SUPPL2012-11-15
25412SUPPL2012-11-13
2966SUPPL2011-11-14
35049SUPPL2011-11-10
25411SUPPL2011-05-10
2965SUPPL2011-03-31
12905SUPPL2011-03-28
25410SUPPL2011-01-14
35048SUPPL2011-01-10
2964SUPPL2010-07-23
35047SUPPL2010-07-22
25409SUPPL2010-01-26
12904SUPPL2010-01-20
2963SUPPL2008-06-30
35045SUPPL2008-06-26
35046SUPPL2007-08-17
25408SUPPL2007-08-17
41513SUPPL2007-08-06
20797SUPPL2007-08-06
20795SUPPL2007-08-06
20793SUPPL2007-08-06
20792SUPPL2007-08-06
25407SUPPL2007-04-20
12903SUPPL2007-04-20
20796SUPPL2005-04-27
35044SUPPL2005-03-02
2962SUPPL2005-03-02
35040SUPPL2004-06-30
25404SUPPL2004-06-30
25403SUPPL2004-06-30
12902SUPPL2004-05-27
2961SUPPL2004-05-26
20794SUPPL2004-02-04
35043SUPPL2003-12-29
2960SUPPL2003-12-23
35042SUPPL2003-08-06
25406SUPPL2003-08-06
35041SUPPL2003-04-04
25405SUPPL2002-03-27