AMONDYS 45 is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Sarepta Therapeutics, Inc.. The primary component is Casimersen.
| Product ID | 60923-227_7d131a39-559d-478b-b221-4f6f4bc91f18 |
| NDC | 60923-227 |
| Product Type | Human Prescription Drug |
| Proprietary Name | AMONDYS 45 |
| Generic Name | Casimersen |
| Dosage Form | Injection |
| Route of Administration | INTRAVENOUS |
| Marketing Start Date | 2021-02-25 |
| Marketing Category | NDA / |
| Application Number | NDA213026 |
| Labeler Name | Sarepta Therapeutics, Inc. |
| Substance Name | CASIMERSEN |
| Active Ingredient Strength | 50 mg/mL |
| NDC Exclude Flag | N |
| Listing Certified Through | 2022-12-31 |
| Marketing Start Date | 2021-02-25 |
| NDC Exclude Flag | N |
| Sample Package? | N |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() AMONDYS 45 90135119 not registered Live/Pending |
Sarepta Therapeutics, Inc. 2020-08-25 |