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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 125338
Company: AUXILIUM PHARMS

Medication Guide

REMS

Summary Review

Products on BLA 125338

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
XIAFLEX	COLLAGENASE CLOSTRIDIUM HISTOLYTICUM	0.9MG	SOLUTION; INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 125338

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/02/2010	ORIG-1	Approval		N/A; Orphan	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125338lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125338s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/125338s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/125338s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/01/2022	SUPPL-129	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125338s129lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125338Orig1s129ltr.pdf
11/02/2022	SUPPL-128	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125338Orig1s128ltr.pdf
06/09/2022	SUPPL-127	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125338Orig1s127ltr.pdf
01/11/2022	SUPPL-121	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125338Orig1s121ltr.pdf
08/19/2021	SUPPL-117	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125338s117lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125338Orig1s117ltr.pdf
04/13/2021	SUPPL-112	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125338s112lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125338Orig1s112ltr.pdf
07/12/2023	SUPPL-111	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125338s111lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/125338Orig1s111ltr.pdf
09/26/2018	SUPPL-110	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125338Orig1s110ltr.pdf
06/06/2018	SUPPL-109	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125338s109lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125338Orig1s109ltr.pdf
09/19/2016	SUPPL-102	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125338s102lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125338Orig1s102ltr.pdf
11/28/2016	SUPPL-101	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125338Orig1s100,125338Orig1s101ltr.pdf
11/28/2016	SUPPL-100	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125338Orig1s100,125338Orig1s101ltr.pdf
05/15/2015	SUPPL-88	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125338s085s087s088lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125338Orig1s085,087,088ltr.pdf
05/15/2015	SUPPL-87	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125338s085s087s088lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125338Orig1s085,087,088ltr.pdf
05/15/2015	SUPPL-85	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125338s085s087s088lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125338Orig1s085,087,088ltr.pdf
10/20/2014	SUPPL-84	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125338s084lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125338Orig1s084ltr.pdf
12/06/2013	SUPPL-61	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125338s0061lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125338Orig1s0061ltr.pdf
02/24/2012	SUPPL-40	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125338s0040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125338s0040ltr.pdf

Labels for BLA 125338

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/12/2023	SUPPL-111	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125338s111lbl.pdf
08/01/2022	SUPPL-129	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125338s129lbl.pdf
08/01/2022	SUPPL-129	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125338s129lbl.pdf
08/19/2021	SUPPL-117	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125338s117lbl.pdf
04/13/2021	SUPPL-112	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125338s112lbl.pdf
04/13/2021	SUPPL-112	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125338s112lbl.pdf
06/06/2018	SUPPL-109	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125338s109lbl.pdf
09/19/2016	SUPPL-102	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125338s102lbl.pdf
05/15/2015	SUPPL-88	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125338s085s087s088lbl.pdf
05/15/2015	SUPPL-87	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125338s085s087s088lbl.pdf
05/15/2015	SUPPL-85	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125338s085s087s088lbl.pdf
10/20/2014	SUPPL-84	Efficacy	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125338s084lbl.pdf
12/06/2013	SUPPL-61	Efficacy	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125338s0061lbl.pdf
02/24/2012	SUPPL-40	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125338s0040lbl.pdf
02/02/2010	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125338lbl.pdf

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