Application 203382

Type
NDA
Sponsor
SANDOZ INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MARAVIROCMARAVIROCTABLET;ORAL150MGNoNo
002MARAVIROCMARAVIROCTABLET;ORAL300MGNoNo

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 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MaravirocMARAVIROCA-S Medication Solutions5c4a1da5-a8e1-4038-970d-fb15c189c35e2026-07-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Maraviroc
generic name: MARAVIROC
MaravirocMARAVIROCA-S Medication Solutions0c5f41e8-d358-403a-b199-6b9028b527482026-06-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Maraviroc
generic name: MARAVIROC
MaravirocMARAVIROCNavinta LLC211290a4-5e26-4784-aa99-8ccaf2eaaa152025-06-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Maraviroc
generic name: MARAVIROC
MaravirocMARAVIROCZydus Pharmaceuticals USA Inc.9bba17ba-0bc5-430c-96d1-c568e236a0ed2025-05-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Maraviroc
generic name: MARAVIROC
MaravirocMARAVIROCA2A Integrated Pharmaceuticals2a16417d-a3b8-483b-9dfe-d5263cc165382025-02-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Maraviroc
generic name: MARAVIROC
SELZENTRYMARAVIROCA-S Medication Solutions3c52dddd-0457-41cd-99e0-d30d4fd00ec52023-11-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MARAVIROC
MaravirocMARAVIROCi3 Pharmaceuticals, LLCf7b9c67b-10c6-45b5-b2a8-952cd350b0b12023-08-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Maraviroc
generic name: MARAVIROC
MaravirocMARAVIROCXLCare Pharmaceuticals Inc.d3a728e2-1866-462e-bfcc-5f3c9dd887942023-07-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Maraviroc
generic name: MARAVIROC
SELZENTRYMARAVIROCViiV Healthcare Company46f30ac5-c96b-429e-976d-8c5ee1c0761b2022-09-26Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MARAVIROC
MaravirocMARAVIROCCamber Pharmaceuticals, Inc.09ec3e79-c0d3-4b8f-80d8-0a854c4ca3392022-01-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Maraviroc
generic name: MARAVIROC

Reported adverse events (FAERS/openFDA)#

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