← FDA DRUG APPROVALS

FDA ANDA · ANDA091387

BALANCED SALT

sodium chloride, potassium chloride, calcium chloride, magnesium chloride, sodium acetate, and sodium citrate

Sponsor: B BRAUN

APPLICATION
ANDA091387
TYPE
ANDA
ORIGINAL APPROVAL
2010-02-03
LATEST ACTION
2022-01-28
ROUTE
IRRIGATION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

BALANCED SALTPrescription
CALCIUM CHLORIDE 0.48MG/ML, MAGNESIUM CHLORIDE 0.3MG/ML, POTASSIUM CHLORIDE 0.75MG/ML, SODIUM ACETATE 3.9MG/ML, SODIUM CHLORIDE 6.4MG/ML, SODIUM CITRATE 1.7MG/ML · SOLUTION · IRRIGATION

Approval history

2022-01-28Manufacturing (CMC) · Supplement 10 · unknownAP
2010-02-03Original — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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.

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