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FDA ANDA · ANDA090273

CICLOPIROX OLAMINE

Sponsor: GLENMARK PHARMS

APPLICATION
ANDA090273
TYPE
ANDA
ORIGINAL APPROVAL
2009-11-10
LATEST ACTION
2026-06-24
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription

Products

CICLOPIROXPrescription
CICLOPIROX 0.77% · CREAM · TOPICAL

Approval history

2026-06-24Labeling · Supplement 7 · standardAP
2016-02-25Labeling · Supplement 2 · standardAP
2009-11-10OriginalAP
VIEW ON DRUGS@FDA ↗

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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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