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Details for New Drug Application (NDA): 020599
NDA 020599 describes RILUTEK, which is a drug marketed by Covis Pharma Bv and is included in one NDA. It is available from two suppliers. Additional details are available on the RILUTEK profile page.
The generic ingredient in RILUTEK is riluzole. There are nine drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the riluzole profile page.
The generic ingredient in RILUTEK is riluzole. There are nine drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the riluzole profile page.
Summary for 020599
| Tradename: | RILUTEK |
| Applicant: | Covis Pharma Bv |
| Ingredient: | riluzole |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 020599
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RILUTEK | riluzole | TABLET;ORAL | 020599 | NDA AUTHORIZED GENERIC | Rising Pharmaceuticals, Inc. | 64980-191 | 64980-191-06 | 60 TABLET, FILM COATED in 1 BOTTLE (64980-191-06) |
| RILUTEK | riluzole | TABLET;ORAL | 020599 | NDA | Covis Pharma | 70515-700 | 70515-700-60 | 1 BOTTLE in 1 CARTON (70515-700-60) > 60 TABLET in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Dec 12, 1995 | TE: | AB | RLD: | Yes | ||||
Expired US Patents for NDA 020599
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Covis Pharma Bv | RILUTEK | riluzole | TABLET;ORAL | 020599-001 | Dec 12, 1995 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
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