FDA.reportPublic FDA data

Application 218519

Type
ANDA
Sponsor
FOSUN WANBANG (JIANGSU) PHARMACEUTICAL GROUP CO.,

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002APIXABANAPIXABANTABLET1.5MGNoNo
003APIXABANAPIXABANTABLET2.0MGNoNo
004APIXABANAPIXABANTABLET5MGNoNo
005APIXABANAPIXABANTABLET2.5MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ELIQUISAPIXABANCardinal Health 107, LLCa454cd24-0c6d-46e8-b1e4-1973886061752026-04-24Boxed warning, Warnings, Adverse reactionsName fallback
generic name: APIXABAN
ELIQUISAPIXABANREMEDYREPACK INC.7be1f4c1-bb2f-4ded-ae9a-515d2a22f93e2025-08-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: APIXABAN
ApixabanAPIXABANMacleods Pharmaceuticals Limited396912c0-9f68-47ed-ba3f-8d9ace755a482025-04-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Apixaban
generic name: APIXABAN
ELIQUISAPIXABANAphena Pharma Solutions - Tennessee, LLC1523ab32-2c2c-6501-e063-6394a90aa0b32025-02-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: APIXABAN
ELIQUISAPIXABANAphena Pharma Solutions - Tennessee, LLC41a133ef-e461-48ad-8221-b735bdd0ec252025-01-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: APIXABAN
ELIQUISAPIXABANA-S Medication Solutions33a9046a-41cc-46c1-becc-2ff4d7d715382024-11-25Boxed warning, Warnings, Adverse reactionsName fallback
generic name: APIXABAN
ELIQUISAPIXABANProficient Rx LP33752f5d-2ca7-45c0-8292-b54742219b972024-06-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: APIXABAN
ApixabanAPIXABANAmneal Pharmaceuticals of New York LLC19a60552-374d-4b8b-a8ce-ceae252ea5ba2024-05-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Apixaban
generic name: APIXABAN
ELIQUISAPIXABANA-S Medication Solutions2f47aa0e-0235-4220-85dd-dfcb8ad0d0092023-05-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: APIXABAN
ELIQUISAPIXABANA-S Medication Solutionsfd383ae7-1e34-44ef-b8f1-ca6906dfbcef2023-05-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: APIXABAN
apixabanAPIXABANIndoco Remedies Limited095a08ac-cf0e-497e-a682-ddef38d6b29c2021-06-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: apixaban
generic name: APIXABAN