← FDA DRUG APPROVALS

FDA ANDA · ANDA214071

IBUPROFEN

Sponsor: STRIDES PHARMA

APPLICATION
ANDA214071
TYPE
ANDA
ORIGINAL APPROVAL
2022-06-09
LATEST ACTION
2023-03-27
ROUTE
ORAL
DOSAGE FORM
SUSPENSION/DROPS
MARKETING STATUS
Discontinued

Products

IBUPROFENDiscontinued
IBUPROFEN 50MG/1.25ML · SUSPENSION/DROPS · ORAL

Approval history

2023-03-27Manufacturing (CMC) · Supplement 1 · unknownAP
2022-06-09UNKNOWN · Original · standardLetterAP
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 →