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 |