← FDA DRUG APPROVALS

FDA ANDA · ANDA065216

NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE

Sponsor: SAPTALIS PHARMS

APPLICATION
ANDA065216
TYPE
ANDA
ORIGINAL APPROVAL
2005-10-31
LATEST ACTION
2005-10-31
ROUTE
OTIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued

Products

NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONEDiscontinued
HYDROCORTISONE 1%, NEOMYCIN SULFATE EQ 3.5MG BASE/ML, POLYMYXIN B SULFATE 10,000 UNITS/ML · SOLUTION/DROPS · OTIC

Approval history

2005-10-31OriginalAP
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.

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 →