Orange Book product · Generic (ANDA)
DECITABINE
DECITABINE
At a glance
Nov 19, 2021
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 19, 2021
4 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
DECITABINE
Strength
50MG/VIAL
Dosage form
INJECTABLE
Route
INTRAVENOUS
TE code
AP
Application
ANDA 214486
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of DECITABINE
- 2014DECITABINEBrand (NDA)
NDA 205582 · SUN PHARM
- 2006DACOGENBrand (NDA)
NDA 021790 · OTSUKA
- 2025DECITABINEGeneric (ANDA)
ANDA 217814 · RELIANCE LIFE SCI
- 2024DECITABINEGeneric (ANDA)
ANDA 215355 · HETERO LABS LTD VI
- 2022DECITABINEGeneric (ANDA)
ANDA 213472 · JIANGSU HANSOH PHARM
- 2021DECITABINEGeneric (ANDA)
ANDA 214569 · EUGIA PHARMA
- 2021DECITABINEGeneric (ANDA)
ANDA 212959 · MEITHEAL
- 2021DECITABINEGeneric (ANDA)
ANDA 212826 · QILU PHARM HAINAN
- 2020DECITABINEGeneric (ANDA)
ANDA 212117 · NIVAGEN PHARMS INC
- 2020DECITABINEGeneric (ANDA)
ANDA 205539 · GLAND
- 2019DECITABINEGeneric (ANDA)
ANDA 210984 · NOVAST LABS
- 2019DECITABINEGeneric (ANDA)
ANDA 212265 · MSN
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.
