Details for New Drug Application (NDA): 213375
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NDA 213375 describes VIGABATRIN, which is a drug marketed by Accord Hlthcare, Alkem Labs Ltd, Amneal Pharms, Annora Pharma, Aurobindo Pharma Ltd, Chartwell Rx, Dexcel, Dr Reddys, Endo Operations, Granules, Invagen Pharms, MSN, Propel Pharma, Specgx Llc, Teva Pharms Usa, Zydus Lifesciences, Hikma, Ryan Labs, and Upsher Smith Labs, and is included in twenty-five NDAs. It is available from fifteen suppliers. Additional details are available on the VIGABATRIN profile page.
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.
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 213375
| Tradename: | VIGABATRIN |
| Applicant: | Alkem Labs Ltd |
| Ingredient: | vigabatrin |
| Patents: | 0 |
Suppliers and Packaging for NDA: 213375
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VIGABATRIN | vigabatrin | FOR SOLUTION;ORAL | 213375 | ANDA | Ascend Laboratories, LLC | 67877-674 | 67877-674-63 | 50 PACKET in 1 CARTON (67877-674-63) / 10 mL in 1 PACKET |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SOLUTION;ORAL | Strength | 500MG/PACKET | ||||
| Approval Date: | Dec 2, 2020 | TE: | AA | RLD: | No | ||||
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