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Generated: November 13, 2018

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Details for New Drug Application (NDA): 020954

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NDA 020954 describes BUSULFEX, which is a drug marketed by Otsuka Pharm and is included in one NDA. It is available from one supplier. Additional details are available on the BUSULFEX profile page.

The generic ingredient in BUSULFEX 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 020954
Tradename:BUSULFEX
Applicant:Otsuka Pharm
Ingredient:busulfan
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020954
Mechanism of ActionAlkylating Activity
Suppliers and Packaging for NDA: 020954
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUSULFEX busulfan INJECTABLE;INJECTION 020954 NDA Otsuka America Pharmaceutical, Inc. 59148-047 59148-047-91 8 VIAL in 1 PACKAGE (59148-047-91) > 10 mL in 1 VIAL (59148-047-90)
BUSULFEX busulfan INJECTABLE;INJECTION 020954 NDA Otsuka America Pharmaceutical, Inc. 59148-070 59148-070-91 8 VIAL in 1 PACKAGE (59148-070-91) > 10 mL in 1 VIAL (59148-070-90)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength6MG/ML
Approval Date:Feb 4, 1999TE:APRLD:Yes

Expired US Patents for NDA 020954

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Otsuka Pharm BUSULFEX busulfan INJECTABLE;INJECTION 020954-001 Feb 4, 1999 ➤ Try a Free Trial ➤ Try a Free Trial
Otsuka Pharm BUSULFEX busulfan INJECTABLE;INJECTION 020954-001 Feb 4, 1999 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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