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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. Two suppliers are listed for this compound. Additional details are available on the busulfan profile page.

Summary for NDA: 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)

Summary for product number 001

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

Expired Orange Book Patents for NDA: 020954

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Otsuka Pharm
BUSULFEX
busulfan
INJECTABLE;INJECTION020954-001Feb 4, 19995,430,057*PED► subscribe
Otsuka Pharm
BUSULFEX
busulfan
INJECTABLE;INJECTION020954-001Feb 4, 19995,559,148*PED► subscribe
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