Application 208078
- Type
- NDA
- Sponsor
- CATALYST PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FIRDAPSE | AMIFAMPRIDINE PHOSPHATE | TABLET;ORAL | EQ 10MG BASE | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 69616-211 | Firdapse | amifampridine phosphate | Catalyst Pharmaceuticals, Inc. | NDA | Current |
| 69616-211 | Firdapse | amifampridine phosphate | Catalyst Pharmaceuticals, Inc. | NDA | Current |
| 69616-211 | Firdapse | amifampridine phosphate | Catalyst Pharmaceuticals, Inc. | NDA | Current |
| 69616-211 | Firdapse | amifampridine phosphate | Catalyst Pharmaceuticals, Inc. | NDA | Current |
| 69616-211 | Firdapse | amifampridine phosphate | Catalyst Pharmaceuticals, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 83604 | SUPPL | 2025-09-30 |
| 83603 | SUPPL | 2025-09-30 |
| 83585 | SUPPL | 2025-09-30 |
| 83586 | SUPPL | 2025-09-29 |
| 78607 | SUPPL | 2024-07-02 |
| 78615 | SUPPL | 2024-06-04 |
| 74271 | SUPPL | 2023-05-16 |
| 74261 | SUPPL | 2023-05-16 |
| 72215 | SUPPL | 2022-10-03 |
| 72214 | SUPPL | 2022-10-03 |
| 72192 | SUPPL | 2022-09-30 |
| 66446 | SUPPL | 2021-03-02 |
| 66441 | SUPPL | 2021-03-02 |
| 56984 | ORIG | 2018-12-21 |
| 56802 | ORIG | 2018-12-19 |
| 56605 | ORIG | 2018-11-30 |
| 56604 | ORIG | 2018-11-30 |