Application 213026
- Type
- NDA
- Sponsor
- SAREPTA THERAPS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | AMONDYS 45 | CASIMERSEN | SOLUTION;INTRAVENOUS | 100 mg/2 mL/VIAL | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 60923-227 | AMONDYS 45 | casimersen | Sarepta Therapeutics, Inc. | NDA | Current |
| 60923-227 | AMONDYS 45 | casimersen | Sarepta Therapeutics, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 84718 | SUPPL | 2026-01-08 |
| 79084 | SUPPL | 2024-07-15 |
| 79069 | SUPPL | 2024-07-15 |
| 73860 | SUPPL | 2023-03-24 |
| 73857 | SUPPL | 2023-03-24 |
| 66805 | ORIG | 2021-03-18 |
| 66413 | ORIG | 2021-03-01 |
| 66411 | ORIG | 2021-02-26 |