Pepaxto is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Oncopeptides, Ab. The primary component is Melphalan Flufenamide.
| Product ID | 73657-020_779bf257-f198-4c8e-8ddf-87d3c14d8c77 |
| NDC | 73657-020 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Pepaxto |
| Generic Name | Melphalan Flufenamide |
| Dosage Form | Injection, Powder, Lyophilized, For Solution |
| Route of Administration | INTRAVENOUS |
| Marketing Start Date | 2021-02-26 |
| Marketing Category | NDA / |
| Application Number | NDA214383 |
| Labeler Name | Oncopeptides, AB |
| Substance Name | MELPHALAN FLUFENAMIDE |
| Active Ingredient Strength | 20 mg/50mL |
| NDC Exclude Flag | N |
| Listing Certified Through | 2022-12-31 |
| Marketing Start Date | 2021-02-26 |
| NDC Exclude Flag | N |
| Sample Package? | N |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() PEPAXTO 79275014 not registered Live/Pending |
Oncopeptides AB 2019-11-05 |