Orange Book product · Brand (NDA)
ZYTIGA
ABIRATERONE ACETATE
At a glance
Apr 28, 2011
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 28, 2011
15 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
ABIRATERONE ACETATE
Strength
250MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 202379
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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.
- 2018YONSABrand (NDA)
NDA 210308 · SUN PHARM
- 2023ABIRATERONE ACETATEGeneric (ANDA)
ANDA 215086 · FLORIDA
- 2023ABIRATERONE ACETATEGeneric (ANDA)
ANDA 210726 · TEVA PHARMS USA
- 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.
