FDA.reportPublic FDA data

Application 077429

Type
ANDA
Sponsor
RANBAXY

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NEVIRAPINENEVIRAPINETABLET; ORAL200MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 ยท 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
brand name: NEVIRAPINE
generic name: NEVIRAPINE
NevirapineNEVIRAPINEMylan Pharmaceuticals Inc.690da74b-2481-47fc-93ae-8340e0caf0a42024-10-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Nevirapine
generic name: NEVIRAPINE
NevirapineNEVIRAPINEAurobindo Pharma Limited8dfe86aa-ea5d-48d2-94a8-1a5506055d702024-09-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Nevirapine
generic name: NEVIRAPINE
NEVIRAPINENEVIRAPINEMacleods Pharmaceuticals Limited2620b114-f53f-44f1-8708-697e863430902024-08-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: NEVIRAPINE
generic name: NEVIRAPINE
NevirapineNEVIRAPINEAurobindo Pharma Limited5f6c3eed-2a5d-46ed-9a7c-59715f338a152024-05-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Nevirapine
generic name: NEVIRAPINE
NevirapineNEVIRAPINEMylan Pharmaceuticals Inc.c6e93829-7024-48f6-8023-da6ff27dfc0a2024-01-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Nevirapine
generic name: NEVIRAPINE
NevirapineNEVIRAPINEMacleods Pharmaceuticals Limitedeffb86cc-4b80-4fac-aaa3-9f373b3d0f7d2023-08-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Nevirapine
generic name: NEVIRAPINE
NevirapineNEVIRAPINECamber Pharmaceuticals, Inc.61409678-d2f6-42cd-b03d-b26b11b396412022-08-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Nevirapine
generic name: NEVIRAPINE
NevirapineNEVIRAPINEAmneal Pharmaceuticals LLC4f065674-4719-4c79-ba0d-549040d77f172012-08-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Nevirapine
generic name: NEVIRAPINE

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31238ORIG2005-06-21