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Generated: May 25, 2019

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Details for New Drug Application (NDA): 009386

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NDA 009386 describes MYLERAN, which is a drug marketed by Aspen Global Inc and Aspen Global and is included in two NDAs. It is available from two suppliers. Additional details are available on the MYLERAN profile page.

The generic ingredient in MYLERAN is busulfan. There are ten drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the busulfan profile page.
Summary for 009386
Applicant:Aspen Global
Formulation / Manufacturing:see details
Pharmacology for NDA: 009386
Mechanism of ActionAlkylating Activity
Suppliers and Packaging for NDA: 009386
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MYLERAN busulfan TABLET;ORAL 009386 NDA Aspen Global Inc. 76388-713 76388-713-25 25 TABLET, FILM COATED in 1 BOTTLE (76388-713-25)

Profile for product number 001

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

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