Orange Book product · Generic (ANDA)
BREXPIPRAZOLE
BREXPIPRAZOLE
At a glance
Sep 26, 2022
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 26, 2022
3 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
BREXPIPRAZOLE
Strength
0.25MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
ANDA 213570
Product number
001
Marketing status
DISCN
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 213683 · ALEMBIC
- 2023BREXPIPRAZOLEGeneric (ANDA)
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 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.
