← FDA DRUG APPROVALS

FDA ANDA · ANDA202850

POLYETHYLENE GLYCOL 3350

Sponsor: ANI PHARMS

APPLICATION
ANDA202850
TYPE
ANDA
ORIGINAL APPROVAL
2015-12-15
LATEST ACTION
2021-11-30
ROUTE
ORAL
DOSAGE FORM
FOR SOLUTION
MARKETING STATUS
Over-the-counter

Products

POLYETHYLENE GLYCOL 3350Over-the-counter
POLYETHYLENE GLYCOL 3350 17GM/PACKET · FOR SOLUTION · ORAL
POLYETHYLENE GLYCOL 3350Over-the-counter
POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL · FOR SOLUTION · ORAL

Approval history

2021-11-30Labeling · Supplement 2 · standardAP
2015-12-15UNKNOWN · OriginalAP
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 →