← FDA DRUG APPROVALS

FDA ANDA · ANDA216424

MEROPENEM

Sponsor: QILU

APPLICATION
ANDA216424
TYPE
ANDA
ORIGINAL APPROVAL
2024-07-22
LATEST ACTION
2026-02-17
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

MEROPENEMPrescription
MEROPENEM 1GM/VIAL · INJECTABLE · INJECTION
MEROPENEMPrescription
MEROPENEM 500MG/VIAL · INJECTABLE · INJECTION

Approval history

2026-02-17Labeling · Supplement 7 · standardAP
2024-07-22UNKNOWN · 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 →