← FDA DRUG APPROVALS

FDA ANDA · ANDA088447

TROPICAMIDE

Sponsor: EPIC PHARMA LLC

APPLICATION
ANDA088447
TYPE
ANDA
ORIGINAL APPROVAL
1985-08-28
LATEST ACTION
1990-11-29
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued

Products

TROPICAMIDEDiscontinued
TROPICAMIDE 1% · SOLUTION/DROPS · OPHTHALMIC

Approval history

1990-11-29Labeling · Supplement 6AP
1985-08-28OriginalAP
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 →