FDA.reportPublic FDA data

Application 207189

Type
ANDA
Sponsor
CIPLA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DARUNAVIRDARUNAVIRTABLET;ORAL75MGNoNo
002DARUNAVIRDARUNAVIRTABLET;ORAL150MGNoNo
003DARUNAVIRDARUNAVIRTABLET;ORAL400MGNoNo
004DARUNAVIRDARUNAVIRTABLET;ORAL600MGNoNo

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 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DarunavirDARUNAVIRBryant Ranch Prepacke80e44f8-1987-4b78-a63d-a4e4d5122ddb2026-03-11Warnings, Adverse reactionsName fallback
brand name: Darunavir
generic name: DARUNAVIR
DarunavirDARUNAVIRNuCare Pharmaceuticals, Inc.42cc1b58-2660-f0be-e063-6394a90abe4c2025-11-05Warnings, Adverse reactionsName fallback
brand name: Darunavir
generic name: DARUNAVIR
DARUNAVIRDARUNAVIRLupin Pharmaceuticals, Inc.56daf67e-7501-4cd5-be22-566d7997d42e2025-10-23Warnings, Adverse reactionsName fallback
brand name: DARUNAVIR
generic name: DARUNAVIR
PREZISTADARUNAVIRJanssen Products LP814301f9-c990-46a5-b481-2879a521a16f2025-08-29Warnings, Adverse reactionsName fallback
generic name: DARUNAVIR
Darunavir 600 and 800 mgDARUNAVIRBryant Ranch Prepackbf99d8b8-c4e0-4cb4-924e-8cdcfd8d1aa12025-06-05Warnings, Adverse reactionsName fallback
generic name: DARUNAVIR
DarunavirDARUNAVIRCamber Pharmaceuticals, Inc.49606d5e-f45f-45eb-9ab8-15aa6a2338752025-03-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Darunavir
generic name: DARUNAVIR
DarunavirDARUNAVIRAurobindo Pharma Limited88910ad0-6dc3-4a47-8a6b-5c6ee79f2a932024-06-22Warnings, Adverse reactionsName fallback
brand name: Darunavir
generic name: DARUNAVIR
DarunavirDARUNAVIRZydus Lifesciences Limited6a029063-b14c-4eee-9958-0d9eecb277262024-04-29Name fallback
brand name: Darunavir
generic name: DARUNAVIR
DarunavirDARUNAVIRViona Pharmaceuticals Inc04a542b3-15ad-4a8a-aab4-ace8e08732f32024-04-29Warnings, Adverse reactionsName fallback
brand name: Darunavir
generic name: DARUNAVIR
darunavirDARUNAVIR 600 MGEXELAN PHARMACEUTICALS INC.ed977166-7ac0-4a8c-a10c-4b19a69403c02024-01-19Warnings, Adverse reactionsName fallback
brand name: darunavir
Darunavir 600 and 800 mgDARUNAVIRCipla USA Inc.5624cc30-d484-458e-b234-9bb745a118ca2024-01-18Warnings, Adverse reactionsName fallback
generic name: DARUNAVIR
DarunavirDARUNAVIRNovadoz Pharmaceuticals LLCea6e0136-75b2-4793-9500-04e6658a0a732023-11-29Warnings, Adverse reactionsName fallback
brand name: Darunavir
generic name: DARUNAVIR
DarunavirDARUNAVIRDr.Reddys Laboratories Incf5c9cb01-6530-4db0-a326-22a499d1efdf2023-11-25Warnings, Adverse reactionsName fallback
brand name: Darunavir
generic name: DARUNAVIR
DarunavirDARUNAVIRAmneal Pharmaceuticals NY LLC92b286d5-1ee5-435b-9e1d-2e95c7f2ec692023-11-21Warnings, Adverse reactionsName fallback
brand name: Darunavir
generic name: DARUNAVIR
DarunavirDARUNAVIRCamber Pharmaceuticals, Inc.64160982-e682-4e8d-8800-a893211122112023-10-05Warnings, Adverse reactionsName fallback
brand name: Darunavir
generic name: DARUNAVIR

Reported adverse events (FAERS/openFDA)#

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