← FDA DRUG APPROVALS

FDA ANDA · ANDA083358

PREDNISOLONE SODIUM PHOSPHATE

Sponsor: EPIC PHARMA LLC

APPLICATION
ANDA083358
TYPE
ANDA
ORIGINAL APPROVAL
1974-08-21
LATEST ACTION
1990-12-31
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued

Products

PREDNISOLONE SODIUM PHOSPHATEDiscontinued
PREDNISOLONE SODIUM PHOSPHATE EQ 0.11% PHOSPHATE · SOLUTION/DROPS · OPHTHALMIC
PREDNISOLONE SODIUM PHOSPHATEDiscontinued
PREDNISOLONE SODIUM PHOSPHATE EQ 0.9% PHOSPHATE · SOLUTION/DROPS · OPHTHALMIC

Approval history

1990-12-31Labeling · Supplement 8AP
1989-06-19Labeling · Supplement 7AP
1974-08-21OriginalAP
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 →