Orange Book product · Brand (NDA)
VIDAZA
AZACITIDINE
At a glance
May 19, 2004
Approved
Brand (NDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 19, 2004
22 yr 5 mo ago
Today
Exclusivity ends · ODE-399
Orphan-drug exclusivity (7 years)
May 20, 2029
in 3 yr
Pharmaceutical detail
Active ingredient
AZACITIDINE
Strength
100MG/VIAL
Dosage form
POWDER
Route
INTRAVENOUS, SUBCUTANEOUS
TE code
AP
Application
NDA 050794
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2020ONUREGBrand (NDA)
NDA 214120 · BRISTOL
- 2016AZACITIDINEBrand (NDA)
NDA 208216 · ACTAVIS LLC
- 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
- 2018AZACITIDINEGeneric (ANDA)
ANDA 207475 · ACCORD HLTHCARE
Marketing exclusivity (1)
- ODE-399Orphan-drug exclusivity (7 years)
May 20, 2029
in 3 yr
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.
