FDA.reportPublic FDA data

Application 218751

Type
ANDA
Sponsor
TEVA PHARMACEUTICALS DEVELOPMENT INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002AZACITIDINEAZACITIDINETABLET300MGNoNo

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 2 · 27 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ONUREGAZACITIDINECelgene Corporation0e95e33f-8aba-4f19-b332-2416580d358b2026-06-12Warnings, Adverse reactionsName fallback
generic name: AZACITIDINE
AzacitidineAZACITIDINEBluePoint Laboratories.cd9db533-8a49-4d01-99e2-b2db8db1ed382026-03-26Warnings, Adverse reactionsName fallback
brand name: Azacitidine
generic name: AZACITIDINE
AzacitidineAZACITIDINEApotex Corpa6a5ca37-37e8-ab65-bc0b-9c0682ab52f72025-09-16Warnings, Adverse reactionsName fallback
brand name: Azacitidine
generic name: AZACITIDINE
AzacitidineAZACITIDINECivica, Inc.2d15b3ec-ed08-48c6-a400-34e55974afad2025-08-25Warnings, Adverse reactionsName fallback
brand name: Azacitidine
generic name: AZACITIDINE
AzacitidineAZACITIDINESomerset Therapeutics LLC3bc4f406-2ec7-7169-e063-6394a90a81d92025-08-07Warnings, Adverse reactionsName fallback
brand name: Azacitidine
generic name: AZACITIDINE
AZACITIDINEAZACITIDINEArmas Pharmaceuticals Inc.5c0a2d5f-8c34-4c04-8425-7543965cedd42025-08-05Warnings, Adverse reactionsName fallback
brand name: AZACITIDINE
generic name: AZACITIDINE
AzacitidineAZACITIDINEMeitheal Pharmaceuticals Inc.3b96b508-046b-49ae-aefe-6d39c89a1d0e2025-07-21Warnings, Adverse reactionsName fallback
brand name: Azacitidine
generic name: AZACITIDINE
AzacitidineAZACITIDINEMeitheal Pharmaceuticals Inc.97b0917a-03fa-4cc4-91cf-1bed57a988c92025-07-21Warnings, Adverse reactionsName fallback
brand name: Azacitidine
generic name: AZACITIDINE
AzacitidineAZACITIDINEFresenius Kabi USA, LLC3b594aba-e798-4105-b801-0b0d970747c12025-06-18Warnings, Adverse reactionsName fallback
brand name: Azacitidine
generic name: AZACITIDINE
AzacitidineAZACITIDINEReliance Life Sciences Private Limited5804d999-96eb-4fd1-b7d8-de7867c5f1d62025-05-29Warnings, Adverse reactionsName fallback
brand name: Azacitidine
generic name: AZACITIDINE
AzacitidineAZACITIDINEBluePoint Laboratories5f0f9ee3-a5b1-4a25-a34c-7f38c8433f4a2025-05-26Warnings, Adverse reactionsName fallback
brand name: Azacitidine
generic name: AZACITIDINE
AzacitidineAZACITIDINECamber Pharmaceuticals, Inc.f02c9bef-e47f-4b70-95f6-9341d87346ed2025-04-08Warnings, Adverse reactionsName fallback
brand name: Azacitidine
generic name: AZACITIDINE
AZACITIDINEAZACITIDINE FORPilnova Pharma Inc0095c67b-42f3-47e6-92db-f77843727bca2024-12-16Warnings, Adverse reactionsName fallback
brand name: AZACITIDINE
AzacitidineAZACITIDINEAccord Healthcare Inc.70140e11-33f1-2240-e053-2991aa0a04802024-12-03Warnings, Adverse reactionsName fallback
brand name: Azacitidine
generic name: AZACITIDINE
AzacitidineAZACITIDINEDr. Reddy's Laboratories Inc.060d56e7-1a24-87c1-7f40-149ecf424f7c2024-10-30Warnings, Adverse reactionsName fallback
brand name: Azacitidine
generic name: AZACITIDINE
AzacitidineAZACITIDINESandoz Inc7f89fcbd-d3f4-4112-8733-69baea41255e2024-10-24Warnings, Adverse reactionsName fallback
brand name: Azacitidine
generic name: AZACITIDINE
AZACITIDINEAZACITIDINEAmneal Pharmaceuticals LLC80a43736-0598-4e4b-85ba-e29daa290c8f2024-08-20Warnings, Adverse reactionsName fallback
brand name: AZACITIDINE
generic name: AZACITIDINE
AzacitidineAZACITIDINEDr. Reddy's Laboratories Inc.71d8d758-86c9-b571-aed1-719654fd4b822024-07-31Warnings, Adverse reactionsName fallback
brand name: Azacitidine
generic name: AZACITIDINE
AzacitidineAZACITIDINEDr. Reddy's Laboratories Inc.33397835-15a9-d89f-bd75-8b915f5c4dbf2024-07-31Warnings, Adverse reactionsName fallback
brand name: Azacitidine
generic name: AZACITIDINE
AzacitidineAZACITIDINENorthStar RxLLC81366ec1-9689-4857-ded6-3d6342fe51322024-07-31Warnings, Adverse reactionsName fallback
brand name: Azacitidine
generic name: AZACITIDINE