← FDA DRUG APPROVALS

FDA BLA · BLA125338

XIAFLEX

collagenase clostridium histolyticum

Sponsor: AUXILIUM PHARMS

APPLICATION
BLA125338
TYPE
BLA
ORIGINAL APPROVAL
2010-02-02
LATEST ACTION
2024-10-11
ROUTE
INJECTION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

XIAFLEXPrescription
COLLAGENASE CLOSTRIDIUM HISTOLYTICUM 0.9MG · SOLUTION · INJECTION

Approval history

2024-10-11REMS · Supplement 138 — Letter ↗AP
2023-07-12Labeling · Supplement 111 · standard — Letter ↗AP
2022-11-02REMS · Supplement 128 — Letter ↗AP
2022-08-01Labeling · Supplement 129 · standard — Letter ↗AP
2022-06-09REMS · Supplement 127 — Letter ↗AP
2022-01-11REMS · Supplement 121 — Letter ↗AP
2021-08-19Labeling · Supplement 117 · standard — Label ↗AP
2021-04-13Labeling · Supplement 112 · standard — Letter ↗AP
2018-09-26REMS · Supplement 110 — Letter ↗AP
2018-06-06Labeling · Supplement 109 · standard — Label ↗AP
2016-11-28REMS · Supplement 100 — Letter ↗AP
2016-11-28REMS · Supplement 101 — Letter ↗AP
2016-09-19Labeling · Supplement 102 · standard — Letter ↗AP
2015-05-15Efficacy · Supplement 87 · standard — Label ↗AP
2015-05-15Efficacy · Supplement 85 · standard — Letter ↗AP
2015-05-15Efficacy · Supplement 88 · standard — Label ↗AP
2014-10-20Efficacy · Supplement 84 · standard — Letter ↗AP
2013-12-06Efficacy · Supplement 61 · standard — Label ↗AP
2012-02-24Labeling · Supplement 40 · standard — Label ↗AP
2010-02-02Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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