Details for New Drug Application (NDA): 014691
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The generic ingredient in ALKERAN is melphalan. There are twelve drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the melphalan profile page.
Summary for 014691
Tradename: | ALKERAN |
Applicant: | Apotex |
Ingredient: | melphalan |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 014691
Mechanism of Action | Alkylating Activity |
Medical Subject Heading (MeSH) Categories for 014691
Suppliers and Packaging for NDA: 014691
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ALKERAN | melphalan | TABLET;ORAL | 014691 | NDA | ApoPharma USA, Inc. | 52609-0001 | 52609-0001-5 | 50 TABLET, FILM COATED in 1 BOTTLE (52609-0001-5) |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes |
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