FDA NDA · NDA016677

SODIUM CHLORIDE

Sponsor: BAXTER HLTHCARE

APPLICATION

NDA016677

TYPE

NDA

ORIGINAL APPROVAL

1970-12-09

LATEST ACTION

2024-07-24

ROUTE

INTRAVENOUS, INJECTION

DOSAGE FORM

SOLUTION

MARKETING STATUS

Prescription

Products

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER · ReferencePrescription

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

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER · ReferencePrescription

SODIUM CHLORIDE 900MG/100ML · SOLUTION · INJECTION

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER · ReferencePrescription

SODIUM CHLORIDE 225MG/25ML (9MG/ML) · SOLUTION · INJECTION

Approval history

2024-07-24Labeling · Supplement 185 · standard — Letter ↗AP

2019-05-29Labeling · Supplement 169 · standard — Label ↗AP

2018-03-09Manufacturing (CMC) · Supplement 160 — Label ↗AP

2016-03-03Manufacturing (CMC) · Supplement 151 · standard — Label ↗AP

2015-05-13Manufacturing (CMC) · Supplement 150 · standard — Label ↗AP

2014-12-22Labeling · Supplement 148 · standard — Letter ↗AP

2014-06-05Manufacturing (CMC) · Supplement 149 · standardAP

2013-09-11Labeling · Supplement 147 · standard — Letter ↗AP

2005-08-26Supplement · Supplement 139 · standard — Letter ↗AP

2005-05-23Labeling · Supplement 137 · standard — Letter ↗AP

2003-07-17Manufacturing (CMC) · Supplement 131 · standard — Letter ↗AP

2002-09-16Manufacturing (CMC) · Supplement 128 · standardAP

2002-04-03Labeling · Supplement 124 · standard — Letter ↗AP

2001-08-14Manufacturing (CMC) · Supplement 126 · standardAP

1999-11-24Manufacturing (CMC) · Supplement 125 · standardAP

1997-12-31Manufacturing (CMC) · Supplement 123 · standardAP

1997-06-10Manufacturing (CMC) · Supplement 121 · standardAP

1997-04-29Manufacturing (CMC) · Supplement 122 · standardAP

1996-11-14Manufacturing (CMC) · Supplement 119 · standardAP

1996-10-11Manufacturing (CMC) · Supplement 120 · standardAP

1995-09-27Manufacturing (CMC) · Supplement 118 · standardAP

1994-09-30Manufacturing (CMC) · Supplement 116 · standardAP

1994-02-18Manufacturing (CMC) · Supplement 117 · standardAP

1993-06-01Manufacturing (CMC) · Supplement 111 · standardAP

1993-01-06Manufacturing (CMC) · Supplement 115 · standardAP

1992-11-23Manufacturing (CMC) · Supplement 110 · standardAP

1991-03-26Manufacturing (CMC) · Supplement 109 · standardAP

1991-02-15Manufacturing (CMC) · Supplement 106 · standardAP

1990-05-24Manufacturing (CMC) · Supplement 108 · standardAP

1990-03-23Manufacturing (CMC) · Supplement 107 · standardAP

1989-07-26Manufacturing (CMC) · Supplement 105 · standardAP

1989-01-12Manufacturing (CMC) · Supplement 104 · standardAP

1989-01-10Manufacturing (CMC) · Supplement 102 · standardAP

1988-06-14Manufacturing (CMC) · Supplement 103 · standardAP

1987-07-25Manufacturing (CMC) · Supplement 100 · standardAP

1987-05-28Manufacturing (CMC) · Supplement 99 · standardAP

1987-04-27Manufacturing (CMC) · Supplement 101 · standardAP

1986-02-27Manufacturing (CMC) · Supplement 96 · standardAP

1985-10-30Labeling · Supplement 89AP

1985-10-30Manufacturing (CMC) · Supplement 88 · standardAP

VIEW ON DRUGS@FDA ↗

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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SODIUM CHLORIDE

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Approval history

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