Details for New Drug Application (NDA): 022311

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NDA 022311 describes MOZOBIL, which is a drug marketed by Genzyme and is included in one NDA. It is available from two suppliers. Additional details are available on the MOZOBIL profile page.

The generic ingredient in MOZOBIL is plerixafor. There are seven drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the plerixafor profile page.

Summary for 022311

Tradename:	MOZOBIL
Applicant:	Genzyme
Ingredient:	plerixafor
Patents:	0

Pharmacology for NDA: 022311

Physiological Effect	Increased Hematopoietic Stem Cell Mobilization

Suppliers and Packaging for NDA: 022311

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MOZOBIL	plerixafor	SOLUTION;SUBCUTANEOUS	022311	NDA	Sanofi-Aventis U.S. LLC	0024-5862	0024-5862-01	1 VIAL, SINGLE-USE in 1 CARTON (0024-5862-01) / 1.2 mL in 1 VIAL, SINGLE-USE
MOZOBIL	plerixafor	SOLUTION;SUBCUTANEOUS	022311	NDA AUTHORIZED GENERIC	Fresenius Kabi Usa, LLC	65219-284	65219-284-12	1 VIAL, SINGLE-USE in 1 CARTON (65219-284-12) / 1.2 mL in 1 VIAL, SINGLE-USE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;SUBCUTANEOUS			Strength	24MG/1.2ML (20MG/ML)
Approval Date:	Dec 15, 2008	TE:	AP	RLD:	Yes

Expired US Patents for NDA 022311

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Genzyme	MOZOBIL	plerixafor	SOLUTION;SUBCUTANEOUS	022311-001	Dec 15, 2008	5,583,131	⤷ Get Started Free
Genzyme	MOZOBIL	plerixafor	SOLUTION;SUBCUTANEOUS	022311-001	Dec 15, 2008	RE42152	⤷ Get Started Free
Genzyme	MOZOBIL	plerixafor	SOLUTION;SUBCUTANEOUS	022311-001	Dec 15, 2008	7,897,590	⤷ Get Started Free
Genzyme	MOZOBIL	plerixafor	SOLUTION;SUBCUTANEOUS	022311-001	Dec 15, 2008	6,987,102	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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