← FDA DRUG APPROVALS

FDA NDA · NDA202106

MEROPENEM AND SODIUM CHLORIDE

Sponsor: B BRAUN MEDICAL

APPLICATION
NDA202106
TYPE
NDA
ORIGINAL APPROVAL
2015-04-30
LATEST ACTION
2024-12-03
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER · ReferencePrescription
MEROPENEM 1GM/VIAL · POWDER · INTRAVENOUS
MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER · ReferencePrescription
MEROPENEM 500MG/VIAL · POWDER · INTRAVENOUS

Approval history

2024-12-03Labeling · Supplement 9 · standard — Letter ↗AP
2020-05-12Labeling · Supplement 7 · standard — Label ↗AP
2018-01-19Labeling · Supplement 3 · standard — Label ↗AP
2015-12-15Manufacturing (CMC) · Supplement 1 · standardAP
2015-04-30Type 4 - New Combination · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA 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 →