EVOMELA is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Cenexi - Bla. The primary component is Melphalan Hydrochloride.
| Product ID | 69605-001_d44fac6f-e1e1-399d-e053-2a95a90a81f1 |
| NDC | 69605-001 |
| Product Type | Human Prescription Drug |
| Proprietary Name | EVOMELA |
| Generic Name | Melphalan |
| Dosage Form | Injection, Powder, Lyophilized, For Solution |
| Route of Administration | INTRAVENOUS |
| Marketing Start Date | 2016-03-31 |
| Marketing Category | NDA / |
| Application Number | NDA207155 |
| Labeler Name | CENEXI - BLA |
| Substance Name | MELPHALAN HYDROCHLORIDE |
| Active Ingredient Strength | 50 mg/10mL |
| Pharm Classes | Alkylating Activity [MoA],Alkylating Drug [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2022-12-31 |
| Marketing Start Date | 2016-03-31 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 68152-109 | EVOMELA | Melphalan |
| 69605-001 | EVOMELA | Melphalan |
| 72893-001 | EVOMELA | Melphalan |
| 52609-0001 | ALKERAN | melphalan |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() EVOMELA 86508057 4994159 Live/Registered |
ACROTECH BIOPHARMA LLC 2015-01-20 |