Details for New Drug Application (NDA): 213899
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The generic ingredient in VIGABATRIN 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 213899
Tradename: | VIGABATRIN |
Applicant: | Aurobindo Pharma Ltd |
Ingredient: | vigabatrin |
Patents: | 0 |
Suppliers and Packaging for NDA: 213899
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
VIGABATRIN | vigabatrin | FOR SOLUTION;ORAL | 213899 | ANDA | Aurobindo Pharma Limited | 59651-366 | 59651-366-50 | 50 PACKET in 1 CARTON (59651-366-50) / 1 POWDER, FOR SOLUTION in 1 PACKET (59651-366-07) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SOLUTION;ORAL | Strength | 500MG/PACKET | ||||
Approval Date: | Sep 29, 2021 | TE: | AA | RLD: | No |
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