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Last Updated: June 9, 2023

Details for New Drug Application (NDA): 014691

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NDA 014691 describes ALKERAN, which is a drug marketed by Apotex and is included in two NDAs. It is available from one supplier. Additional details are available on the ALKERAN profile page.

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
Formulation / Manufacturing:see details
Pharmacology for NDA: 014691
Mechanism of ActionAlkylating 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:DISCNDosage:TABLET;ORALStrength2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

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