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FDA NDA · NDA050819

ACANYA

clindamycin phosphate and benzoyl peroxide

Sponsor: BAUSCH

APPLICATION
NDA050819
TYPE
NDA
ORIGINAL APPROVAL
2008-10-23
LATEST ACTION
2025-07-11
ROUTE
TOPICAL
DOSAGE FORM
GEL
MARKETING STATUS
Prescription

Products

ACANYA · ReferencePrescription
BENZOYL PEROXIDE 2.5%, CLINDAMYCIN PHOSPHATE EQ 1.2% BASE · GEL · TOPICAL
ONEXTON · ReferencePrescription
BENZOYL PEROXIDE 3.75%, CLINDAMYCIN PHOSPHATE EQ 1.2% BASE · GEL · TOPICAL

Approval history

2025-07-11Manufacturing (CMC) · Supplement 29 — Letter ↗AP
2020-02-21Labeling · Supplement 23 · standard — Letter ↗AP
2020-02-21Labeling · Supplement 24 · standard — Letter ↗AP
2016-03-25Manufacturing (CMC) · Supplement 16 · standardAP
2015-11-19Manufacturing (CMC) · Supplement 14 · standardAP
2015-10-08Manufacturing (CMC) · Supplement 15 · standardAP
2015-09-10Manufacturing (CMC) · Supplement 13 · standardAP
2014-11-24Efficacy · Supplement 12 · standard — Label ↗AP
2014-03-18Manufacturing (CMC) · Supplement 11 · standardAP
2014-02-28Labeling · Supplement 10 · standard — Label ↗AP
2012-12-18Manufacturing (CMC) · Supplement 9 · standardAP
2010-10-18Labeling · Supplement 3 · unknown — Label ↗AP
2010-06-23Labeling · Supplement 2 · standard — Label ↗AP
2008-10-23Type 5 - New Formulation or New Manufacturer · Original · standard — Review ↗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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