Orange Book product · Generic (ANDA)
AZACITIDINE
AZACITIDINE
At a glance
May 20, 2025
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 20, 2025
1 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
AZACITIDINE
Strength
100MG/VIAL
Dosage form
POWDER
Route
INTRAVENOUS, SUBCUTANEOUS
TE code
AP
Application
ANDA 217453
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of AZACITIDINE
- 2020ONUREGBrand (NDA)
NDA 214120 · BRISTOL
- 2016AZACITIDINEBrand (NDA)
NDA 208216 · ACTAVIS LLC
- 2004VIDAZABrand (NDA)
NDA 050794 · BRISTOL-MYERS
- 2024AZACITIDINEGeneric (ANDA)
ANDA 215765 · HETERO LABS LTD VI
- 2024AZACITIDINEGeneric (ANDA)
ANDA 212580 · MSN LABS PVT LTD
- 2023AZACITIDINEGeneric (ANDA)
ANDA 215905 · JIANGSU HANSOH PHARM
- 2022AZACITIDINEGeneric (ANDA)
ANDA 215066 · EUGIA PHARMA
- 2022AZACITIDINEGeneric (ANDA)
ANDA 211549 · AMNEAL
- 2020AZACITIDINEGeneric (ANDA)
ANDA 212128 · MEITHEAL
- 2020AZACITIDINEGeneric (ANDA)
ANDA 209337 · EUROHLTH INTL SARL
- 2019AZACITIDINEGeneric (ANDA)
ANDA 210748 · LUPIN
- 2018AZACITIDINEGeneric (ANDA)
ANDA 207475 · ACCORD HLTHCARE
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
