Details for New Drug Application (NDA): 091394
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NDA 091394 describes RILUZOLE, which is a drug marketed by Alkem Labs Ltd, Apotex Corp, Daito Pharms Co Ltd, Glenmark Pharms Ltd, Impax Labs, Kenton, Mylan Pharms Inc, and Sun Pharm Inds Ltd, and is included in nine NDAs. It is available from six suppliers. Additional details are available on the RILUZOLE profile page.
The generic ingredient in RILUZOLE is riluzole. There are nine drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the riluzole profile page.
The generic ingredient in RILUZOLE is riluzole. There are nine drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the riluzole profile page.
Summary for 091394
| Tradename: | RILUZOLE |
| Applicant: | Glenmark Pharms Ltd |
| Ingredient: | riluzole |
| Patents: | 0 |
Suppliers and Packaging for NDA: 091394
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RILUZOLE | riluzole | TABLET;ORAL | 091394 | ANDA | Glenmark Pharmaceuticals Inc., USA | 68462-381 | 68462-381-10 | 1000 TABLET, FILM COATED in 1 BOTTLE (68462-381-10) |
| RILUZOLE | riluzole | TABLET;ORAL | 091394 | ANDA | Glenmark Pharmaceuticals Inc., USA | 68462-381 | 68462-381-60 | 60 TABLET, FILM COATED in 1 BOTTLE (68462-381-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Jun 18, 2013 | TE: | AB | RLD: | No | ||||
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