Details for New Drug Application (NDA): 213469
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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 213469
Tradename: | VIGABATRIN |
Applicant: | Granules |
Ingredient: | vigabatrin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 213469
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
VIGABATRIN | vigabatrin | FOR SOLUTION;ORAL | 213469 | ANDA | Hikma Pharmaceuticals USA Inc. | 0054-0702 | 0054-0702-19 | 50 PACKET in 1 CARTON (0054-0702-19) / 10 mL in 1 PACKET |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | FOR SOLUTION;ORAL | Strength | 500MG/PACKET | ||||
Approval Date: | Apr 24, 2020 | TE: | RLD: | No |
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