Details for New Drug Application (NDA): 213669
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The generic ingredient in BREXPIPRAZOLE is brexpiprazole. There are eight drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the brexpiprazole profile page.
Summary for 213669
Tradename: | BREXPIPRAZOLE |
Applicant: | Hetero Labs Ltd V |
Ingredient: | brexpiprazole |
Patents: | 0 |
Suppliers and Packaging for NDA: 213669
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BREXPIPRAZOLE | brexpiprazole | TABLET;ORAL | 213669 | ANDA | Camber Pharmaceuticals, Inc. | 31722-434 | 31722-434-30 | 1 BOTTLE in 1 CARTON (31722-434-30) / 30 TABLET, FILM COATED in 1 BOTTLE |
BREXPIPRAZOLE | brexpiprazole | TABLET;ORAL | 213669 | ANDA | Camber Pharmaceuticals, Inc. | 31722-435 | 31722-435-30 | 1 BOTTLE in 1 CARTON (31722-435-30) / 30 TABLET, FILM COATED in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.25MG | ||||
Approval Date: | Nov 20, 2023 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.5MG | ||||
Approval Date: | Nov 20, 2023 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
Approval Date: | Nov 20, 2023 | TE: | AB | RLD: | No |
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