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. Eleven 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

Pharmacology for NDA: 020954

Mechanism of Action	Alkylating Activity

Medical Subject Heading (MeSH) Categories for 020954

Alkylating Agents
Antineoplastic Agents, Alkylating
Immunosuppressive Agents
Myeloablative Agonists

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.	59148-070	59148-070-91	8 CARTON in 1 CARTON (59148-070-91) / 1 VIAL in 1 CARTON (59148-070-90) / 10 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	6MG/ML
Approval Date:	Feb 4, 1999	TE:	AP	RLD:	Yes

Expired US Patents for NDA 020954

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Otsuka Pharm	BUSULFEX	busulfan	INJECTABLE;INJECTION	020954-001	Feb 4, 1999	5,430,057*PED	⤷ Get Started Free
Otsuka Pharm	BUSULFEX	busulfan	INJECTABLE;INJECTION	020954-001	Feb 4, 1999	5,559,148*PED	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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