Details for New Drug Application (NDA): 208218
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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 208218
Tradename: | VIGABATRIN |
Applicant: | Endo Operations |
Ingredient: | vigabatrin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 208218
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
VIGABATRIN | vigabatrin | FOR SOLUTION;ORAL | 208218 | ANDA | ENDO USA, Inc. | 49884-358 | 49884-358-03 | 50 PACKET in 1 CARTON (49884-358-03) / 10 mL in 1 PACKET (49884-358-52) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SOLUTION;ORAL | Strength | 500MG/PACKET | ||||
Approval Date: | Apr 27, 2017 | TE: | AA | RLD: | No |
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