Details for New Drug Application (NDA): 217684
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NDA 217684 describes VIGAFYDE, which is a drug marketed by Pyros Pharms and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the VIGAFYDE profile page.
The generic ingredient in VIGAFYDE is vigabatrin. There are five drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the vigabatrin profile page.
The generic ingredient in VIGAFYDE is vigabatrin. There are five drug master file entries for this compound. Sixteen 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: | 2 |
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 | Upsher-Smith Laboratories, LLC | 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: | 12,016,857 | Patent Expiration: | Aug 16, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 12,290,499 | Patent Expiration: | Oct 17, 2042 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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