Details for New Drug Application (NDA): 020427
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NDA 020427 describes SABRIL, which is a drug marketed by Lundbeck Pharms Llc and is included in two NDAs. It is available from one supplier. Additional details are available on the SABRIL profile page.
The generic ingredient in SABRIL 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 SABRIL 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 020427
| Tradename: | SABRIL |
| Applicant: | Lundbeck Pharms Llc |
| Ingredient: | vigabatrin |
| Patents: | 0 |
Suppliers and Packaging for NDA: 020427
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SABRIL | vigabatrin | TABLET;ORAL | 020427 | NDA | Lundbeck Pharmaceuticals LLC | 67386-111 | 67386-111-01 | 100 TABLET, FILM COATED in 1 BOTTLE (67386-111-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
| Approval Date: | Aug 21, 2009 | TE: | AB | RLD: | Yes | ||||
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