← FDA DRUG APPROVALS

FDA ANDA · ANDA218067

ERTAPENEM

ertapenem sodium

Sponsor: QILU ANTIBIOTICS

APPLICATION
ANDA218067
TYPE
ANDA
ORIGINAL APPROVAL
2024-10-31
LATEST ACTION
2024-10-31
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INTRAMUSCULAR, INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

ERTAPENEM SODIUMPrescription
ERTAPENEM SODIUM EQ 1GM BASE/VIAL · INJECTABLE · INTRAMUSCULAR, INTRAVENOUS

Approval history

2024-10-31UNKNOWN · 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 →