Details for New Drug Application (NDA): 213562
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NDA 213562 describes BREXPIPRAZOLE, which is a drug marketed by Ajanta Pharma Ltd, Alkem Labs Ltd, Amneal, Anda Repository, Aurobindo Pharma Ltd, Hetero Labs Ltd V, Lupin Ltd, Sandoz, Teva Pharms Usa Inc, and Zydus Pharms, and is included in ten NDAs. It is available from two suppliers. Additional details are available on the BREXPIPRAZOLE profile page.
The generic ingredient in BREXPIPRAZOLE is brexpiprazole. There are eight drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the brexpiprazole profile page.
The generic ingredient in BREXPIPRAZOLE is brexpiprazole. There are eight drug master file entries for this compound. Four 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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