Details for New Drug Application (NDA): 213718
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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 213718
Tradename: | BREXPIPRAZOLE |
Applicant: | Ajanta Pharma Ltd |
Ingredient: | brexpiprazole |
Patents: | 0 |
Suppliers and Packaging for NDA: 213718
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BREXPIPRAZOLE | brexpiprazole | TABLET;ORAL | 213718 | ANDA | Ajanta Pharma USA Inc. | 27241-204 | 27241-204-30 | 30 TABLET in 1 BOTTLE (27241-204-30) |
BREXPIPRAZOLE | brexpiprazole | TABLET;ORAL | 213718 | ANDA | Ajanta Pharma USA Inc. | 27241-205 | 27241-205-30 | 30 TABLET in 1 BOTTLE (27241-205-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 0.25MG | ||||
Approval Date: | Feb 3, 2023 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 0.5MG | ||||
Approval Date: | Feb 3, 2023 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
Approval Date: | Feb 3, 2023 | TE: | RLD: | No |
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