FDA.reportPublic FDA data

Application 209944

Type
ANDA
Sponsor
SUNSHINE LAKE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001APIXABANAPIXABANTABLET;ORAL2.GMGNoNo
002APIXABANAPIXABANTABLET;ORAL5MGNoNo

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 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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
57983ORIG2019-03-13