Details for New Drug Application (NDA): 213390
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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 213390
Tradename: | VIGABATRIN |
Applicant: | Propel Pharma |
Ingredient: | vigabatrin |
Patents: | 0 |
Suppliers and Packaging for NDA: 213390
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
VIGABATRIN | vigabatrin | FOR SOLUTION;ORAL | 213390 | ANDA | Biocon Pharma Inc. | 70377-089 | 70377-089-01 | 50 PACKET in 1 CARTON (70377-089-01) / 10 mL in 1 PACKET |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SOLUTION;ORAL | Strength | 500MG/PACKET | ||||
Approval Date: | Jul 29, 2021 | TE: | AA | RLD: | No |
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