← FDA DRUG APPROVALS

FDA ANDA · ANDA218273

CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE

Sponsor: COSETTE PHARMS NC

APPLICATION
ANDA218273
TYPE
ANDA
ORIGINAL APPROVAL
2025-11-10
LATEST ACTION
2025-11-10
ROUTE
AURICULAR (OTIC), OTIC
DOSAGE FORM
SUSPENSION/DROPS
MARKETING STATUS
Prescription

Products

CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONEPrescription
CIPROFLOXACIN HYDROCHLORIDE EQ 0.2% BASE, HYDROCORTISONE 1% · SUSPENSION/DROPS · OTIC

Approval history

2025-11-10UNKNOWN · Original · standardLetterAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA 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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →