Details for New Drug Application (NDA): 213562
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The generic ingredient in BREXPIPRAZOLE is brexpiprazole. There are eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the brexpiprazole profile page.
Summary for 213562
Tradename: | BREXPIPRAZOLE |
Applicant: | Amneal |
Ingredient: | brexpiprazole |
Patents: | 0 |
Suppliers and Packaging for NDA: 213562
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BREXPIPRAZOLE | brexpiprazole | TABLET;ORAL | 213562 | ANDA | Amneal Pharmaceuticals NY LLC | 60219-1649 | 60219-1649-3 | 1 BOTTLE, PLASTIC in 1 CARTON (60219-1649-3) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC |
BREXPIPRAZOLE | brexpiprazole | TABLET;ORAL | 213562 | ANDA | Amneal Pharmaceuticals NY LLC | 60219-1650 | 60219-1650-3 | 1 BOTTLE, PLASTIC in 1 CARTON (60219-1650-3) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 0.25MG | ||||
Approval Date: | Jan 31, 2023 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 0.5MG | ||||
Approval Date: | Jan 31, 2023 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
Approval Date: | Jan 31, 2023 | TE: | RLD: | No |
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