Application 211970
- Type
- NDA
- Sponsor
- SAREPTA THERAPS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | VYONDYS 53 | GOLODIRSEN | SOLUTION;INTRAVENOUS | 100MG/2ML (50MG/ML) | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 60923-465 | Vyondys 53 | golodirsen | Sarepta Therapeutics, Inc. | NDA | Current |
| 60923-465 | Vyondys 53 | golodirsen | Sarepta Therapeutics, Inc. | NDA | Current |
| 60923-465 | Vyondys 53 | golodirsen | Sarepta Therapeutics, Inc. | NDA | Current |
| 60923-465 | Vyondys 53 | golodirsen | Sarepta Therapeutics, Inc. | NDA | Current |
| 60923-465 | Vyondys 53 | golodirsen | Sarepta Therapeutics, Inc. | NDA | Current |
| 60923-465 | Vyondys 53 | golodirsen | Sarepta Therapeutics, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 78634 | SUPPL | 2024-07-02 |
| 78633 | SUPPL | 2024-07-02 |
| 78644 | SUPPL | 2024-06-05 |
| 78643 | SUPPL | 2024-06-05 |
| 66232 | SUPPL | 2021-02-16 |
| 66215 | SUPPL | 2021-02-16 |
| 61605 | ORIG | 2020-01-21 |
| 61266 | ORIG | 2019-12-13 |
| 61260 | ORIG | 2019-12-13 |