Details for New Drug Application (NDA): 210196
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NDA 210196 describes VIGADRONE, which is a drug marketed by Aucta and is included in one NDA. It is available from one supplier. Additional details are available on the VIGADRONE profile page.
The generic ingredient in VIGADRONE 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 VIGADRONE 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 210196
| Tradename: | VIGADRONE |
| Applicant: | Aucta |
| Ingredient: | vigabatrin |
| Patents: | 0 |
Suppliers and Packaging for NDA: 210196
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VIGADRONE | vigabatrin | FOR SOLUTION;ORAL | 210196 | ANDA | Upsher-Smith Laboratories, LLC | 0245-0556 | 0245-0556-50 | 50 PACKET in 1 CARTON (0245-0556-50) / 10 mL in 1 PACKET (0245-0556-89) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SOLUTION;ORAL | Strength | 500MG/PACKET | ||||
| Approval Date: | Jun 21, 2018 | TE: | AA | RLD: | No | ||||
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