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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 125117
Company: BIOMARIN

Products on BLA 125117

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NAGLAZYME	GALSULFASE	5MG/5ML	INJECTABLE; INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 125117

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/31/2005	ORIG-1	Approval		N/A; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/125117_0000_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/125117_0000_ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/125117s000_NaglazyneTOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/17/2019	SUPPL-129	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125117s129lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125117Orig1s129ltr.pdf
03/26/2013	SUPPL-111	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125117s111lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125117Orig1s111ltr.pdf
04/28/2011	SUPPL-90	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125117s0086s0088s0090lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125117s086s088s090ltr.pdf
04/28/2011	SUPPL-88	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125117s0086s0088s0090lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125117s086s088s090ltr.pdf
04/28/2011	SUPPL-86	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125117s0086s0088s0090lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125117s086s088s090ltr.pdf

Labels for BLA 125117

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/17/2019	SUPPL-129	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125117s129lbl.pdf
03/26/2013	SUPPL-111	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125117s111lbl.pdf
04/28/2011	SUPPL-90	Efficacy	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125117s0086s0088s0090lbl.pdf
04/28/2011	SUPPL-88	Efficacy	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125117s0086s0088s0090lbl.pdf
04/28/2011	SUPPL-86	Efficacy	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125117s0086s0088s0090lbl.pdf
05/31/2005	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/125117_0000_lbl.pdf

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