Details for New Drug Application (NDA): 214961
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NDA 214961 describes VIGPODER, which is a drug marketed by Pyros Pharms and is included in one NDA. It is available from one supplier. Additional details are available on the VIGPODER profile page.
The generic ingredient in VIGPODER 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.
The generic ingredient in VIGPODER 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 214961
| Tradename: | VIGPODER |
| Applicant: | Pyros Pharms |
| Ingredient: | vigabatrin |
| Patents: | 0 |
Suppliers and Packaging for NDA: 214961
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VIGPODER | vigabatrin | FOR SOLUTION;ORAL | 214961 | ANDA | Pyros Pharmaceuticals, Inc. | 80789-117 | 80789-117-50 | 50 PACKET in 1 CARTON (80789-117-50) / 10 mL in 1 PACKET (80789-117-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SOLUTION;ORAL | Strength | 500MG/PACKET | ||||
| Approval Date: | Jun 24, 2022 | TE: | AA | RLD: | No | ||||
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