Application 020599
- Type
- NDA
- Sponsor
- COVIS PHARMA BV
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | RILUTEK | RILUZOLE | TABLET;ORAL | 50MG | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 64980-191 | Riluzole | riluzole | Rising Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 70515-700 | Rilutek | riluzole | Covis Pharma | NDA | Current |
| 70515-700 | Rilutek | riluzole | Covis Pharma US, Inc | NDA | Current |
| 70515-700 | Rilutek | riluzole | Covis Pharma US, Inc | NDA | Current |
| 70515-700 | Rilutek | riluzole | Covis Pharma | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 83349 | SUPPL | 2025-09-12 |
| 83342 | SUPPL | 2025-09-12 |
| 83341 | SUPPL | 2025-09-12 |
| 62943 | SUPPL | 2020-05-13 |
| 62918 | SUPPL | 2020-05-12 |
| 57674 | ORIG | 2019-02-15 |
| 34937 | SUPPL | 2016-04-12 |
| 2842 | SUPPL | 2016-04-11 |
| 20756 | SUPPL | 2016-02-02 |
| 20755 | SUPPL | 2016-02-02 |
| 41466 | SUPPL | 2015-07-20 |
| 41465 | SUPPL | 2015-07-20 |
| 41468 | SUPPL | 2015-03-10 |
| 41467 | SUPPL | 2015-03-10 |
| 20757 | SUPPL | 2015-03-10 |
| 25291 | SUPPL | 2010-01-20 |
| 12820 | SUPPL | 2009-11-17 |
| 34936 | SUPPL | 2009-07-23 |
| 12819 | SUPPL | 2009-07-23 |
| 25290 | SUPPL | 2009-07-17 |
| 2841 | SUPPL | 2009-07-17 |
| 2840 | SUPPL | 2004-09-24 |
| 25289 | SUPPL | 2003-06-08 |
| 2839 | SUPPL | 2003-06-08 |
| 2838 | SUPPL | 2003-06-08 |