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Harvard Business School

Last Updated: November 28, 2023

Details for New Drug Application (NDA): 009386

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NDA 009386 describes MYLERAN, which is a drug marketed by Waylis Therap and is included in one NDA. 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. Thirteen suppliers are listed for this compound. Additional details are available on the busulfan profile page.
Summary for 009386
Applicant:Waylis Therap
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 Woodward Pharma Services LLC 69784-620 69784-620-25 25 TABLET, FILM COATED in 1 BOTTLE (69784-620-25)
MYLERAN busulfan TABLET;ORAL 009386 NDA Waylis Therapeutics LLC 80725-620 80725-620-25 25 TABLET, FILM COATED in 1 BOTTLE (80725-620-25)

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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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Boehringer Ingelheim

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