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FDA NDA · NDA202832

SODIUM CHLORIDE

Sponsor: MEDEFIL INC

APPLICATION
NDA202832
TYPE
NDA
ORIGINAL APPROVAL
2012-01-06
LATEST ACTION
2022-10-26
ROUTE
INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued, Prescription

Products

SODIUM CHLORIDE 0.9% · ReferenceDiscontinued
SODIUM CHLORIDE 9MG/ML (9MG/ML) · INJECTABLE · INJECTION
SODIUM CHLORIDE 0.9% · ReferencePrescription
SODIUM CHLORIDE 90MG/10ML (9MG/ML) · INJECTABLE · INJECTION
SODIUM CHLORIDE 0.9% · ReferenceDiscontinued
SODIUM CHLORIDE 27MG/3ML (9MG/ML) · INJECTABLE · INJECTION
SODIUM CHLORIDE 0.9% · ReferenceDiscontinued
SODIUM CHLORIDE 18MG/2ML (9MG/ML) · INJECTABLE · INJECTION
SODIUM CHLORIDE 0.9% · ReferenceDiscontinued
SODIUM CHLORIDE 45MG/5ML (9MG/ML) · INJECTABLE · INJECTION
SODIUM CHLORIDE 0.9% · ReferenceDiscontinued
SODIUM CHLORIDE 22.5MG/2.5ML (9MG/ML) · INJECTABLE · INJECTION

Approval history

2022-10-26Labeling · Supplement 6 · standard — Letter ↗AP
2017-11-29Labeling · Supplement 2 · standard — Letter ↗AP
2012-09-27Labeling · Supplement 1 · unknown — Label ↗AP
2012-01-06Type 5 - New Formulation or New Manufacturer · Original · standard — Review ↗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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