← FDA DRUG APPROVALS

FDA ANDA · ANDA084855

DEXAMETHASONE SODIUM PHOSPHATE

Sponsor: EPIC PHARMA LLC

APPLICATION
ANDA084855
TYPE
ANDA
ORIGINAL APPROVAL
1976-06-29
LATEST ACTION
1992-02-05
ROUTE
OTIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued

Products

DEXAMETHASONE SODIUM PHOSPHATEDiscontinued
DEXAMETHASONE SODIUM PHOSPHATE EQ 0.1% PHOSPHATE · SOLUTION/DROPS · OTIC

Approval history

1992-02-05Labeling · Supplement 11AP
1990-04-11Labeling · Supplement 10AP
1976-06-29OriginalAP
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 →