Orange Book product · Generic (ANDA)
BREXPIPRAZOLE
BREXPIPRAZOLE
At a glance
Jan 13, 2025
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 13, 2025
1 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
BREXPIPRAZOLE
Strength
0.25MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 213683
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of BREXPIPRAZOLE
- 2015REXULTIBrand (NDA)
NDA 205422 · OTSUKA
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ANDA 213731 · APOTEX
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ANDA 213782 · ALKEM LABS LTD
- 2023BREXPIPRAZOLEGeneric (ANDA)
ANDA 213669 · HETERO LABS LTD V
- 2023BREXPIPRAZOLEGeneric (ANDA)
ANDA 213659 · AUROBINDO PHARMA LTD
- 2023BREXPIPRAZOLEGeneric (ANDA)
ANDA 213758 · CHARTWELL RX
- 2023BREXPIPRAZOLEGeneric (ANDA)
ANDA 213512 · LUPIN
- 2023BREXPIPRAZOLEGeneric (ANDA)
ANDA 213718 · AJANTA PHARMA LTD
- 2023BREXPIPRAZOLEGeneric (ANDA)
ANDA 213562 · AMNEAL
- 2023BREXPIPRAZOLEGeneric (ANDA)
ANDA 213660 · ZYDUS PHARMS
- 2022BREXPIPRAZOLEGeneric (ANDA)
ANDA 213570 · SANDOZ
- 2022BREXPIPRAZOLEGeneric (ANDA)
ANDA 213692 · TEVA PHARMS USA INC
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.
