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Details for New Drug Application (NDA): 014691
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 Inc |
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 | N | 52609-0001-5 |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes |
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