Details for New Drug Application (NDA): 210155
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NDA 210155 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, Granules, Invagen Pharms, MSN, Par Pharm Inc, Propel Pharma, Specgx Llc, Teva Pharms Usa, Zydus, Hikma, and Upsher Smith Labs, and is included in twenty-five NDAs. It is available from sixteen 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. Eighteen 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. Eighteen 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 |
| Formulation / Manufacturing: | see details |
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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