← FDA DRUG APPROVALS

FDA ANDA · ANDA060751

NEO-CORTEF

Sponsor: PHARMACIA AND UPJOHN

APPLICATION
ANDA060751
TYPE
ANDA
ORIGINAL APPROVAL
1965-05-18
LATEST ACTION
1993-01-22
ROUTE
TOPICAL
DOSAGE FORM
OINTMENT
MARKETING STATUS
Discontinued

Products

NEO-CORTEFDiscontinued
HYDROCORTISONE ACETATE 2.5%, NEOMYCIN SULFATE EQ 3.5MG BASE/GM · OINTMENT · TOPICAL
NEO-CORTEFDiscontinued
HYDROCORTISONE ACETATE 0.5%, NEOMYCIN SULFATE EQ 3.5MG BASE/GM · OINTMENT · TOPICAL
NEO-CORTEFDiscontinued
HYDROCORTISONE ACETATE 1%, NEOMYCIN SULFATE EQ 3.5MG BASE/GM · OINTMENT · TOPICAL

Approval history

1993-01-22Manufacturing (CMC) · Supplement 8AP
1992-06-23Manufacturing (CMC) · Supplement 6AP
1991-04-22Manufacturing (CMC) · Supplement 7AP
1991-03-04Manufacturing (CMC) · Supplement 5AP
1965-05-18OriginalAP
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 →