Details for New Drug Application (NDA): 213519
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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 213519
Tradename: | VIGABATRIN |
Applicant: | Annora Pharma |
Ingredient: | vigabatrin |
Patents: | 0 |
Suppliers and Packaging for NDA: 213519
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
VIGABATRIN | vigabatrin | FOR SOLUTION;ORAL | 213519 | ANDA | Camber Pharmaceuticals, Inc. | 31722-009 | 31722-009-50 | 50 PACKET in 1 CARTON (31722-009-50) / 10 mL in 1 PACKET |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SOLUTION;ORAL | Strength | 500MG/PACKET | ||||
Approval Date: | Jan 26, 2021 | TE: | AA | RLD: | No |
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