← FDA DRUG APPROVALS

FDA ANDA · ANDA217236

IBUPROFEN

Sponsor: PATHEON SOFTGELS

APPLICATION
ANDA217236
TYPE
ANDA
ORIGINAL APPROVAL
2024-02-13
LATEST ACTION
2024-02-13
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Over-the-counter

Products

IBUPROFENOver-the-counter
IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT · CAPSULE · ORAL

Approval history

2024-02-13UNKNOWN · Original · standardAP
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 →