Orange Book product · Generic (ANDA)
AZACITIDINE
AZACITIDINE
At a glance
Apr 28, 2016
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 28, 2016
10 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
AZACITIDINE
Strength
100MG/VIAL
Dosage form
POWDER
Route
INTRAVENOUS, SUBCUTANEOUS
TE code
Not listed
Application
ANDA 204949
Product number
001
Marketing status
DISCN
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
- 2025AZACITIDINEGeneric (ANDA)
ANDA 217453 · RELIANCE LIFE
- 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
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.
