Details for New Drug Application (NDA): 210155
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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 210155
Tradename: | VIGABATRIN |
Applicant: | Amneal Pharms |
Ingredient: | vigabatrin |
Patents: | 0 |
Suppliers and Packaging for NDA: 210155
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
VIGABATRIN | vigabatrin | FOR SOLUTION;ORAL | 210155 | ANDA | Amneal Pharmaceuticals NY LLC | 60219-1425 | 60219-1425-5 | 50 FOR SOLUTION in 1 CARTON (60219-1425-5) |
VIGABATRIN | vigabatrin | FOR SOLUTION;ORAL | 210155 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-1425 | 69238-1425-5 | 50 FOR SOLUTION in 1 CARTON (69238-1425-5) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SOLUTION;ORAL | Strength | 500MG/PACKET | ||||
Approval Date: | Mar 13, 2018 | TE: | AA | RLD: | No |
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