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Details for New Drug Application (NDA): 014691

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NDA 014691 describes ALKERAN, which is a drug marketed by Apotex Inc 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. One supplier is listed for this compound. Additional details are available on the melphalan profile page.

Summary for NDA: 014691

Tradename:
ALKERAN
Applicant:
Apotex Inc
Ingredient:
melphalan
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 014691

Mechanism of ActionAlkylating Activity

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 Apo-Pharma USA, Inc 52609-0001 52609-0001-5 50 TABLET, FILM COATED in 1 BOTTLE (52609-0001-5)

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes


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