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#

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 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