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Generated: November 19, 2018

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Details for New Drug Application (NDA): 208536

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NDA 208536 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. Eight suppliers are listed for this compound. Additional details are available on the busulfan profile page.
Summary for 208536
Tradename:MYLERAN
Applicant:Aspen Global Inc
Ingredient:busulfan
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 208536
Mechanism of ActionAlkylating Activity
Suppliers and Packaging for NDA: 208536
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MYLERAN busulfan INJECTABLE;INJECTION 208536 ANDA Mylan Institutional LLC 67457-893 67457-893-08 8 VIAL, SINGLE-DOSE in 1 CARTON (67457-893-08) > 10 mL in 1 VIAL, SINGLE-DOSE (67457-893-00)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength6MG/ML
Approval Date:Nov 20, 2017TE:APRLD:No

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