Details for New Drug Application (NDA): 207155
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NDA 207155 describes EVOMELA, which is a drug marketed by Acrotech Biopharma and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug and one Paragraph IV challenge. Additional details are available on the EVOMELA profile page.
The generic ingredient in EVOMELA is melphalan hydrochloride. There are twelve drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the melphalan hydrochloride profile page.
The generic ingredient in EVOMELA is melphalan hydrochloride. There are twelve drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the melphalan hydrochloride profile page.
Summary for 207155
| Tradename: | EVOMELA |
| Applicant: | Acrotech Biopharma |
| Ingredient: | melphalan hydrochloride |
| Patents: | 7 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 207155
| Mechanism of Action | Alkylating Activity |
Suppliers and Packaging for NDA: 207155
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EVOMELA | melphalan hydrochloride | POWDER;INTRAVENOUS | 207155 | NDA | Acrotech Biopharma LLC | 72893-001 | 72893-001-01 | 1 VIAL in 1 CARTON (72893-001-01) / 20 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | EQ 50MG BASE/VIAL | ||||
| Approval Date: | Mar 10, 2016 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Mar 10, 2023 | ||||||||
| Regulatory Exclusivity Use: | FOR HIGH-DOSE CONDITIONING TREATMENT PRIOR TO HEMATOPOIETIC PROGENITOR (STEM) CELL TRANSPLANTATION IN PATIENTS WITH MULTIPLE MYELOMA | ||||||||
| Patent: | See Plans and Pricing | Patent Expiration: | Jan 30, 2034 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | See Plans and Pricing | Patent Expiration: | May 28, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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