Orange Book product · Generic (ANDA)
ARIPIPRAZOLE
ARIPIPRAZOLE
At a glance
Oct 22, 2025
Approved
Generic (ANDA)
Application
AA
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 22, 2025
8 mo ago
Today
Pharmaceutical detail
Active ingredient
ARIPIPRAZOLE
Strength
1MG/ML
Dosage form
SOLUTION
Route
ORAL
TE code
AA
Application
ANDA 215582
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of ARIPIPRAZOLE
- 2025MEZOFYBrand (NDA)
NDA 211448 · CMG PHARM CO LTD
- 2024OPIPZABrand (NDA)
NDA 216655 · XIAMEN LP PHARM CO
- 2023ABILIFY ASIMTUFIIBrand (NDA)
NDA 217006 · OTSUKA
- 2017ABILIFY MYCITE KITBrand (NDA)
NDA 207202 · OTSUKA
- 2013ABILIFY MAINTENA KITBrand (NDA)
NDA 202971 · OTSUKA PHARM CO LTD
- 2006ABILIFYBrand (NDA)
NDA 021866 · OTSUKA
- 2006ABILIFYBrand (NDA)
NDA 021729 · OTSUKA
- 2004ABILIFYBrand (NDA)
NDA 021713 · OTSUKA
- 2002ABILIFYBrand (NDA)
NDA 021436 · OTSUKA
- 2026ARIPIPRAZOLEGeneric (ANDA)
ANDA 216208 · AUROBINDO PHARMA
- 2024ARIPIPRAZOLEGeneric (ANDA)
ANDA 216608 · MYLAN
- 2024ARIPIPRAZOLEGeneric (ANDA)
ANDA 205589 · 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.
