FDA NDA · NDA021569

SODIUM CHLORIDE

Sponsor: LIEBEL-FLARSHEIM

APPLICATION

NDA021569

TYPE

NDA

ORIGINAL APPROVAL

2006-07-27

LATEST ACTION

2018-12-29

ROUTE

INTRAVASCULAR, INJECTION

DOSAGE FORM

INJECTABLE

MARKETING STATUS

Prescription, Discontinued

Products

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER · ReferencePrescription

SODIUM CHLORIDE 1.125GM/125ML (9MG/ML) · INJECTABLE · INJECTION

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER · ReferenceDiscontinued

SODIUM CHLORIDE 450MG/50ML (9MG/ML) · INJECTABLE · INJECTION

2018-12-29Labeling · Supplement 9 · standard — Label ↗AP

2013-06-10Manufacturing (CMC) · Supplement 7 · standardAP

2012-03-02Labeling · Supplement 4 · standard — Letter ↗AP

2009-10-01Labeling · Supplement 3 · standard — Label ↗AP

2008-04-25Labeling · Supplement 2 · standard — Label ↗AP

2006-07-27Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP

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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