FDA.reportPublic FDA data

Application 071056

Type
ANDA
Sponsor
QUAD PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AZATHIOPRINEAZATHIOPRINE SODIUMInjectable; InjectionEQ 100MG BASE/VIALNoNo

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 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AzathioprineAZATHIOPRINENuCare Pharmaceuticals,Inc.5116b22b-1460-5535-e063-6394a90acbe52026-05-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Azathioprine
AzathioprineAZATHIOPRINEREMEDYREPACK INC.f251f372-c881-483e-8035-c6a8a6bfb4e82026-04-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Azathioprine
AZATHIOPRINEAZATHIOPRINEPD-Rx Pharmaceuticals, Inc.d288e484-32fc-4b46-b504-d75a0fac86632026-02-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: AZATHIOPRINE
AZATHIOPRINEAZATHIOPRINEAvKAREf93d9408-7b3f-b423-e053-6294a90a31ec2026-01-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: AZATHIOPRINE
AZATHIOPRINEAZATHIOPRINEAvKAREd4c7d621-9642-4027-e053-2995a90a92202026-01-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: AZATHIOPRINE
AzathioprineAZATHIOPRINEOceanside Pharmaceuticalsd72ede2c-1a9b-4717-80a7-b76a6a4999362025-09-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Azathioprine
AzathioprineAZATHIOPRINEAmerican Health Packaging040d010a-b1b2-4db7-905d-8aa7f1bab0cd2025-05-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Azathioprine
AzathioprineAZATHIOPRINEAscend Laboratories, LLCbc6dc4bd-2121-4613-9d90-4a504010c98a2025-04-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Azathioprine
AZATHIOPRINEAZATHIOPRINERising Pharma Holdings, Inc.2ffa2fce-895d-469e-8667-b078560aec5f2025-02-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: AZATHIOPRINE
Azathioprine SodiumAZATHIOPRINE SODIUMHikma Pharmaceuticals USA Inc.9ffe79a1-ac91-4a7b-a9e3-7c84bfa9ddf02025-01-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AZATHIOPRINE SODIUM
AzathioprineAZATHIOPRINEGolden State Medical Supply, Inc.8429e025-b79d-dae7-e053-2a91aa0a7fe52025-01-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Azathioprine
AzathioprineAZATHIOPRINENuCare Pharmaceuticals, Inc.2b9f91b9-7959-65e7-e063-6294a90a36802025-01-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Azathioprine
AzathioprineAZATHIOPRINEZydus Lifesciences Limited89b272f0-ef5c-49e4-820f-fcd7ea8ef0662024-11-25Name fallback
brand name: Azathioprine
AzathioprineAZATHIOPRINEZydus Lifesciences Limitedd65bc662-2ae8-4ddb-acc8-f616e72e61402024-11-25Name fallback
brand name: Azathioprine
AzathioprineAZATHIOPRINEZydus Pharmaceuticals USA Inc.b1b0fa3e-11c3-46d0-9537-6b372c2a1b562024-08-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Azathioprine
AZATHIOPRINEAZATHIOPRINEAmneal Pharmaceuticals NY LLCc49b7cc5-0eed-43b7-b7ad-cbb1b6f0cd2c2021-02-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: AZATHIOPRINE
AZATHIOPRINEAZATHIOPRINEAphena Pharma Solutions - Tennessee, LLC2f994aed-f8e7-4967-a167-b22b783b41922018-09-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: AZATHIOPRINE

Reported adverse events (FAERS/openFDA)#

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