← FDA DRUG APPROVALS

FDA ANDA · ANDA215371

MULTIPLE ELECTROLYTES PH 7.4

sodium chloride, sodium gluconate, sodium acetate, potassium chloride and magnesium chloride

Sponsor: FRESENIUS KABI USA

APPLICATION
ANDA215371
TYPE
ANDA
ORIGINAL APPROVAL
2022-06-08
LATEST ACTION
2022-06-08
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 7.4Prescription
MAGNESIUM CHLORIDE 30MG/100ML, POTASSIUM CHLORIDE 37MG/100ML, SODIUM ACETATE 368MG/100ML, SODIUM CHLORIDE 526MG/100ML, SODIUM GLUCONATE 502MG/100ML · INJECTABLE · INJECTION

Approval history

2022-06-08UNKNOWN · Original · standard — Letter ↗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 →