FDA NDA · NDA020178

SODIUM CHLORIDE

Sponsor: BAXTER HLTHCARE

APPLICATION

NDA020178

TYPE

NDA

ORIGINAL APPROVAL

1992-12-07

LATEST ACTION

2022-12-07

ROUTE

INTRAVENOUS, INJECTION

DOSAGE FORM

SOLUTION

MARKETING STATUS

Prescription

Products

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER · ReferencePrescription

SODIUM CHLORIDE 900MG/100ML · SOLUTION · INJECTION

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER · ReferencePrescription

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

2022-12-07Manufacturing (CMC) · Supplement 31 — Letter ↗AP

2020-01-27Manufacturing (CMC) · Supplement 23 — Letter ↗AP

2019-05-29Labeling · Supplement 21 · standard — Label ↗AP

2015-11-23Labeling · Supplement 13 · standard — Letter ↗AP

2015-07-28Manufacturing (CMC) · Supplement 15 · standardAP

2001-05-04Manufacturing (CMC) · Supplement 6 · standardAP

1999-09-14Labeling · Supplement 5AP

1997-12-29Manufacturing (CMC) · Supplement 4 · standardAP

1994-09-30Manufacturing (CMC) · Supplement 1 · standardAP

1994-07-15Manufacturing (CMC) · Supplement 3 · standardAP

1994-02-18Manufacturing (CMC) · Supplement 2 · standardAP

1992-12-07Type 5 - New Formulation or New Manufacturer · Original · standardAP

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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