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Application 209080
- Type
- NDA
- Sponsor
- ITALFARMACO SPA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TIGLUTIK KIT | RILUZOLE | SUSPENSION;ORAL | 50MG/10ML | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 70726-0303 | TIGLUTIK | Riluzole | Itf Pharma, Inc. | NDA | Current |
| 70726-0303 | TIGLUTIK | Riluzole | Itf Pharma, Inc. | NDA | Current |
| 70726-0303 | TIGLUTIK | Riluzole | Itf Pharma, Inc. | NDA | Current |
| 70726-0303 | TIGLUTIK | Riluzole | Itf Pharma, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 83350 | SUPPL | 2025-09-12 |
| 83343 | SUPPL | 2025-09-12 |
| 62945 | SUPPL | 2020-05-13 |
| 62917 | SUPPL | 2020-05-12 |
| 61297 | SUPPL | 2019-12-17 |
| 61283 | SUPPL | 2019-12-16 |
| 57950 | ORIG | 2019-03-11 |
| 55452 | ORIG | 2018-09-12 |
| 55389 | ORIG | 2018-09-06 |