FDA.reportPublic FDA data

Application 216143

Type
ANDA
Sponsor
RHODES PHARMS

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A216143-001MARAVIROCMARAVIROC150MGTABLET / ORAL2025-11-04
A216143-002MARAVIROCMARAVIROC300MGTABLET / ORAL2025-11-04

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
2026-02-19 14:30 UTC2026-02A216143-001MARAVIROC150MGTABLET / ORALAB2025-11-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216143-002MARAVIROC300MGTABLET / ORALAB2025-11-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216143-001MARAVIROC150MGTABLET / ORALAB2025-11-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216143-002MARAVIROC300MGTABLET / ORALAB2025-11-0431067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216143-001MARAVIROC150MGTABLET / ORAL2025-11-04a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216143-002MARAVIROC300MGTABLET / ORAL2025-11-04a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A216143-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216143-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216143-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216143-002AB131067a03dcf5…

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 · 11 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
MaravirocMARAVIROCHetero Labs Limited9db91945-127e-4bb6-970a-ff1e36dde6582024-07-04Boxed 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