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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 125141
Company: GENZYME

Products on BLA 125141

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MYOZYME	ALGLUCOSIDASE ALFA	20MG/KG	INJECTABLE; IV (INFUSION)	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 125141

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/28/2006	ORIG-1	Approval		N/A; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125141LBLini.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/125141s0_LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/125141s000_MyozymeTOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/18/2020	SUPPL-223	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125141s223lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125141Orig1s223,125291Orig1s151ltr.pdf
05/30/2019	SUPPL-222	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125141s222lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125141Orig1s222, 125291Orig1s148ltr.pdf
05/20/2014	SUPPL-219	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125141s219lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125141Orig1s219ltr.pdf
07/09/2012	SUPPL-176	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125141s0176lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125141Orig1s0176ltr.pdf
06/11/2010	SUPPL-116	Supplement		Label is not available on this site.
12/08/2008	SUPPL-74	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125141_74lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125141s074ltr.pdf

Labels for BLA 125141

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/18/2020	SUPPL-223	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125141s223lbl.pdf
05/30/2019	SUPPL-222	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125141s222lbl.pdf
05/20/2014	SUPPL-219	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125141s219lbl.pdf
07/09/2012	SUPPL-176	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125141s0176lbl.pdf
12/08/2008	SUPPL-74	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125141_74lbl.pdf
04/28/2006	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125141LBLini.pdf

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