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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022311
Company: GENZYME

Summary Review

Products on NDA 022311

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MOZOBIL	PLERIXAFOR	24MG/1.2ML (20MG/ML)	SOLUTION;SUBCUTANEOUS	Prescription	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022311

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/15/2008	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022311lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022311s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022311s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022311s000_SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/21/2023	SUPPL-23	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022311s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022311Orig1s023ltr.pdf
08/19/2020	SUPPL-22	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022311s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022311Orig1s022ltr.pdf
05/30/2019	SUPPL-20	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022311s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022311Orig1s020ltr.pdf
12/01/2017	SUPPL-18	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022311s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022311s018ltr.pdf
05/12/2016	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
08/04/2015	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022311s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022311Orig1s016ltr.pdf
12/04/2014	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022311s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022311Orig1s015ltr.pdf
11/12/2013	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
06/04/2013	SUPPL-13	Labeling-Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022311s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022311Orig1s013ltr.pdf
02/26/2013	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
06/14/2010	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022311s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022311s001ltr.pdf

Labels for NDA 022311

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/21/2023	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022311s023lbl.pdf
08/19/2020	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022311s022lbl.pdf
05/30/2019	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022311s020lbl.pdf
12/01/2017	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022311s018lbl.pdf
08/04/2015	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022311s016lbl.pdf
12/04/2014	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022311s015lbl.pdf
06/04/2013	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022311s013lbl.pdf
06/04/2013	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022311s013lbl.pdf
06/14/2010	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022311s001lbl.pdf
12/15/2008	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022311lbl.pdf

Therapeutic Equivalents for NDA 022311

MOZOBIL

SOLUTION;SUBCUTANEOUS; 24MG/1.2ML (20MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MOZOBIL	PLERIXAFOR	24MG/1.2ML (20MG/ML)	SOLUTION;SUBCUTANEOUS	Prescription	Yes	AP	022311	GENZYME
PLERIXAFOR	PLERIXAFOR	24MG/1.2ML (20MG/ML)	SOLUTION;SUBCUTANEOUS	Prescription	No	AP	215334	AMNEAL
PLERIXAFOR	PLERIXAFOR	24MG/1.2ML (20MG/ML)	SOLUTION;SUBCUTANEOUS	Prescription	No	AP	205182	DR REDDYS
PLERIXAFOR	PLERIXAFOR	24MG/1.2ML (20MG/ML)	SOLUTION;SUBCUTANEOUS	Prescription	No	AP	213672	EUGIA PHARMA
PLERIXAFOR	PLERIXAFOR	24MG/1.2ML (20MG/ML)	SOLUTION;SUBCUTANEOUS	Prescription	No	AP	215698	KINDOS
PLERIXAFOR	PLERIXAFOR	24MG/1.2ML (20MG/ML)	SOLUTION;SUBCUTANEOUS	Prescription	No	AP	211901	MSN
PLERIXAFOR	PLERIXAFOR	24MG/1.2ML (20MG/ML)	SOLUTION;SUBCUTANEOUS	Prescription	No	AP	205197	TEVA PHARMS USA INC
PLERIXAFOR	PLERIXAFOR	24MG/1.2ML (20MG/ML)	SOLUTION;SUBCUTANEOUS	Prescription	No	AP	208980	ZYDUS PHARMS

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