Details for New Drug Application (NDA): 217684
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The generic ingredient in VIGAFYDE is vigabatrin. There are five drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the vigabatrin profile page.
Summary for 217684
Tradename: | VIGAFYDE |
Applicant: | Pyros Pharms |
Ingredient: | vigabatrin |
Patents: | 1 |
Suppliers and Packaging for NDA: 217684
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
VIGAFYDE | vigabatrin | SOLUTION;ORAL | 217684 | NDA | Pyros Pharmaceuticals, Inc. | 80789-003 | 80789-003-15 | 1 BOTTLE in 1 CARTON (80789-003-15) / 150 mL in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 100MG/ML | ||||
Approval Date: | Jun 17, 2024 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Aug 16, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? |
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