Details for New Drug Application (NDA): 215707
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The generic ingredient in VIGABATRIN is vigabatrin. There are five drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the vigabatrin profile page.
Summary for 215707
Tradename: | VIGABATRIN |
Applicant: | Zydus Lifesciences |
Ingredient: | vigabatrin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 215707
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
VIGABATRIN | vigabatrin | TABLET;ORAL | 215707 | ANDA | Zydus Pharmaceuticals (USA) Inc. | 70710-1287 | 70710-1287-1 | 100 TABLET, FILM COATED in 1 BOTTLE (70710-1287-1) |
VIGABATRIN | vigabatrin | TABLET;ORAL | 215707 | ANDA | Zydus Lifesciences Limited | 70771-1654 | 70771-1654-1 | 100 TABLET, FILM COATED in 1 BOTTLE (70771-1654-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
Approval Date: | Jan 19, 2022 | TE: | AB | RLD: | No |
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