FDA.reportPublic FDA data

Application 208775

Type
NDA
Sponsor
CIPLA LIMITED

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ABACAVIR AND LAMIVUDINEABACAVIR; LAMIVUDINETABLET, FOR SUSPENSION;ORAL120MG;60MGNoNo

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 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ABACAVIR and LAMIVUDINEABACAVIR AND LAMIVUDINECamber Pharmaceuticals, Inc.e8988924-c18c-4e91-ab79-2d84e72bfa0d2025-05-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ABACAVIR and LAMIVUDINE
Abacavir and LamivudineABACAVIR AND LAMIVUDINEMacleods Pharmaceuticals Limitedd36624c8-d773-4f99-81fc-433fae17feb32025-03-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Abacavir and Lamivudine
Abacavir and LamivudineABACAVIR AND LAMIVUDINEAurobindo Pharma Limiteddeda1a24-2f51-4601-9881-347f472709402024-05-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Abacavir and Lamivudine
Abacavir and LamivudineABACAVIR AND LAMIVUDINELupin Pharmaceuticals, Inc.1d8e7bb9-8624-4739-9719-fe25109d63652023-10-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Abacavir and Lamivudine
Abacavir and LamivudineABACAVIR AND LAMIVUDINECipla USA Inc.c0488bee-2f18-4e2e-8e11-68543c023dec2022-01-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Abacavir and Lamivudine

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.