← FDA DRUG APPROVALS

FDA NDA · NDA217628

CLOTIC (CLOTRIMAZOLE) OTIC SOLUTION

clotrimazole

Sponsor: CARWIN PHARM ASSOC

APPLICATION
NDA217628
TYPE
NDA
ORIGINAL APPROVAL
2025-09-26
LATEST ACTION
2025-09-26
ROUTE
AURICULAR (OTIC), OTIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription

Products

CLOTIC · ReferencePrescription
CLOTRIMAZOLE 1% · SOLUTION/DROPS · OTIC

Approval history

2025-09-26Type 3 - New Dosage Form · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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