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FDA NDA · NDA018016

SODIUM CHLORIDE

Sponsor: BAXTER HLTHCARE

APPLICATION
NDA018016
TYPE
NDA
ORIGINAL APPROVAL
1979-02-02
LATEST ACTION
2024-07-24
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER · ReferencePrescription
SODIUM CHLORIDE 450MG/100ML · INJECTABLE · INJECTION

Approval history

2024-07-24Labeling · Supplement 71 · standard — Letter ↗AP
2019-05-29Labeling · Supplement 67 · standard — Label ↗AP
2014-12-22Labeling · Supplement 62 · standard — Letter ↗AP
2013-09-11Labeling · Supplement 61 · standard — Letter ↗AP
2005-08-26Manufacturing (CMC) · Supplement 57 · standard — Letter ↗AP
2005-05-23Labeling · Supplement 56 · standard — Label ↗AP
2003-07-17Manufacturing (CMC) · Supplement 53 · standard — Letter ↗AP
2002-04-03Labeling · Supplement 49 · standard — Letter ↗AP
2001-08-14Manufacturing (CMC) · Supplement 51 · standardAP
1999-11-24Manufacturing (CMC) · Supplement 50 · standardAP
1997-04-29Manufacturing (CMC) · Supplement 48 · standardAP
1994-09-30Manufacturing (CMC) · Supplement 46 · standardAP
1994-02-18Manufacturing (CMC) · Supplement 47 · standardAP
1991-04-29Manufacturing (CMC) · Supplement 44 · standardAP
1991-03-26Manufacturing (CMC) · Supplement 43 · standardAP
1991-02-15Manufacturing (CMC) · Supplement 41 · standardAP
1990-05-24Manufacturing (CMC) · Supplement 42 · standardAP
1989-07-26Manufacturing (CMC) · Supplement 40 · standardAP
1987-07-25Manufacturing (CMC) · Supplement 39 · standardAP
1987-05-28Manufacturing (CMC) · Supplement 38 · standardAP
1986-02-27Manufacturing (CMC) · Supplement 36 · standardAP
1985-08-28Manufacturing (CMC) · Supplement 29 · standardAP
1985-08-28Manufacturing (CMC) · Supplement 28 · standardAP
1985-06-13Manufacturing (CMC) · Supplement 33 · standardAP
1985-04-18Labeling · Supplement 34AP
1985-04-15Manufacturing (CMC) · Supplement 35 · standardAP
1985-01-24Manufacturing (CMC) · Supplement 26 · standardAP
1984-09-22Manufacturing (CMC) · Supplement 32 · standardAP
1984-03-16Manufacturing (CMC) · Supplement 27 · standardAP
1984-02-28Manufacturing (CMC) · Supplement 31 · standardAP
1983-07-11Labeling · Supplement 22AP
1982-06-22Manufacturing (CMC) · Supplement 24 · standardAP
1982-06-03Manufacturing (CMC) · Supplement 19 · standardAP
1982-04-16Manufacturing (CMC) · Supplement 18 · standardAP
1981-12-21Manufacturing (CMC) · Supplement 16 · standardAP
1981-11-20Manufacturing (CMC) · Supplement 21 · standardAP
1981-08-26Labeling · Supplement 17AP
1981-06-29Manufacturing (CMC) · Supplement 14 · standardAP
1981-04-16Manufacturing (CMC) · Supplement 11 · standardAP
1981-01-21Manufacturing (CMC) · Supplement 13 · standardAP
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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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