Orange Book product · Generic (ANDA)
ABIRATERONE ACETATE
ABIRATERONE ACETATE
At a glance
Jan 26, 2023
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 26, 2023
3 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
ABIRATERONE ACETATE
Strength
500MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
ANDA 210726
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of ABIRATERONE ACETATE
- 2018YONSABrand (NDA)
NDA 210308 · SUN PHARM
- 2011ZYTIGABrand (NDA)
NDA 202379 · JANSSEN BIOTECH
- 2023ABIRATERONE ACETATEGeneric (ANDA)
ANDA 215086 · FLORIDA
- 2022ABIRATERONE ACETATEGeneric (ANDA)
ANDA 212206 · TEVA PHARMS USA
- 2022ABIRATERONE ACETATEGeneric (ANDA)
ANDA 215947 · NOVUGEN
- 2020ABIRATERONE ACETATEGeneric (ANDA)
ANDA 208416 · DR REDDYS
- 2019ABIRATERONE ACETATEGeneric (ANDA)
ANDA 209227 · GLENMARK SPECLT
- 2019ABIRATERONE ACETATEGeneric (ANDA)
ANDA 212462 · QILU
- 2019ABIRATERONE ACETATEGeneric (ANDA)
ANDA 210686 · MSN
- 2019ABIRATERONE ACETATEGeneric (ANDA)
ANDA 208380 · WOCKHARDT BIO AG
- 2019ABIRATERONE ACETATEGeneric (ANDA)
ANDA 208371 · RISING
- 2019ABIRATERONE ACETATEGeneric (ANDA)
ANDA 208327 · AMNEAL PHARMS
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.
