← FDA DRUG APPROVALS

FDA ANDA · ANDA071320

COLOVAGE

Sponsor: DYNAPHARM

APPLICATION
ANDA071320
TYPE
ANDA
ORIGINAL APPROVAL
1988-04-20
LATEST ACTION
1988-08-29
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Discontinued

Products

COLOVAGEDiscontinued
POLYETHYLENE GLYCOL 3350 227.1GM/PACKET, POTASSIUM CHLORIDE 2.82GM/PACKET, SODIUM BICARBONATE 6.36GM/PACKET, SODIUM CHLORIDE 5.53GM/PACKET, SODIUM SULFATE ANHYDROUS 21.5GM/PACKET · FOR SUSPENSION · ORAL

Approval history

1988-08-29Labeling · Supplement 1AP
1988-04-20OriginalAP
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 →