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Details for New Drug Application (NDA): 020599
The generic ingredient in RILUTEK is riluzole. There are nine drug master file entries for this compound. Nine 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 |
Therapeutic Class: | Central Nervous System Agents |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 020599
Ingredient-type | Benzothiazoles |
Medical Subject Heading (MeSH) Categories for 020599
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 | KAISER FOUNDATION HOSPITALS | 0179-0143 | N | 0179-0143-70 |
RILUTEK | riluzole | TABLET;ORAL | 020599 | NDA AUTHORIZED GENERIC | Rising Pharmaceuticals, Inc. | 64980-191 | N | 64980-191-06 |
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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