← FDA DRUG APPROVALS

FDA ANDA · ANDA087996

MYMETHAZINE FORTIS

Sponsor: USL PHARMA

APPLICATION
ANDA087996
TYPE
ANDA
ORIGINAL APPROVAL
1983-01-18
LATEST ACTION
1983-01-18
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Discontinued

Products

MYMETHAZINE FORTISDiscontinued
PROMETHAZINE HYDROCHLORIDE 25MG/5ML · SYRUP · ORAL

Approval history

1983-01-18OriginalAP
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 →