← FDA DRUG APPROVALS

FDA ANDA · ANDA060700

NEO-SYNALAR

neomycin sulfate and fluocinolone acetonide

Sponsor: EUROFARMA

APPLICATION
ANDA060700
TYPE
ANDA
ORIGINAL APPROVAL
1963-06-11
LATEST ACTION
2015-02-25
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription

Products

NEO-SYNALARPrescription
FLUOCINOLONE ACETONIDE 0.025%, NEOMYCIN SULFATE EQ 3.5MG BASE/GM · CREAM · TOPICAL

Approval history

2015-02-25Manufacturing (CMC) · Supplement 18 · unknownAP
1992-11-18Manufacturing (CMC) · Supplement 17AP
1992-03-18Manufacturing (CMC) · Supplement 16AP
1992-03-12Labeling · Supplement 15AP
1991-01-31Manufacturing (CMC) · Supplement 13AP
1963-06-11OriginalAP
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 →