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FDA NDA · NDA017634

POTASSIUM CHLORIDE IN DEXTROSE

potassium chloride and dextrose monohydrate

Sponsor: BAXTER HLTHCARE

APPLICATION
NDA017634
TYPE
NDA
ORIGINAL APPROVAL
1979-02-01
LATEST ACTION
2019-07-15
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

DEXTROSE 5% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER · ReferencePrescription
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 224MG/100ML · INJECTABLE · INJECTION
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER · ReferencePrescription
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 150MG/100ML · INJECTABLE · INJECTION
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER · ReferencePrescription
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 75MG/100ML · INJECTABLE · INJECTION
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER · ReferencePrescription
DEXTROSE 5GM/100ML, POTASSIUM CHLORIDE 300MG/100ML · INJECTABLE · INJECTION

Approval history

2019-07-15Labeling · Supplement 76 · standard — Letter ↗AP
2017-05-26Labeling · Supplement 73 · standard — Letter ↗AP
2017-05-26Labeling · Supplement 71 · standard — Letter ↗AP
2014-12-22Labeling · Supplement 69 · standard — Letter ↗AP
2014-09-25Manufacturing (CMC) · Supplement 70 · standardAP
2005-08-26Manufacturing (CMC) · Supplement 65 · standard — Letter ↗AP
2005-05-23Labeling · Supplement 64 · standard — Letter ↗AP
2003-01-03Labeling · Supplement 59 · standard — Letter ↗AP
2001-08-14Manufacturing (CMC) · Supplement 60 · standardAP
1999-11-24Manufacturing (CMC) · Supplement 58 · standardAP
1997-04-29Manufacturing (CMC) · Supplement 57 · standardAP
1994-09-30Manufacturing (CMC) · Supplement 55 · standardAP
1994-02-18Manufacturing (CMC) · Supplement 56 · standardAP
1992-02-14Manufacturing (CMC) · Supplement 54 · standardAP
1991-04-29Manufacturing (CMC) · Supplement 52 · standardAP
1991-03-26Manufacturing (CMC) · Supplement 51 · standardAP
1991-02-15Manufacturing (CMC) · Supplement 50 · standardAP
1989-07-26Manufacturing (CMC) · Supplement 49 · standardAP
1989-01-12Manufacturing (CMC) · Supplement 48 · standardAP
1987-07-25Manufacturing (CMC) · Supplement 47 · standardAP
1987-05-28Manufacturing (CMC) · Supplement 46 · standardAP
1986-02-27Manufacturing (CMC) · Supplement 43 · standardAP
1985-08-28Manufacturing (CMC) · Supplement 34 · standardAP
1985-08-28Manufacturing (CMC) · Supplement 35 · standardAP
1985-06-26Labeling · Supplement 41AP
1985-06-13Manufacturing (CMC) · Supplement 39 · standardAP
1985-04-15Manufacturing (CMC) · Supplement 42 · standardAP
1985-01-24Manufacturing (CMC) · Supplement 32 · standardAP
1984-10-23Manufacturing (CMC) · Supplement 38 · standardAP
1984-03-16Manufacturing (CMC) · Supplement 33 · standardAP
1984-02-28Manufacturing (CMC) · Supplement 37 · standardAP
1983-07-11Labeling · Supplement 27AP
1983-03-01Labeling · Supplement 14AP
1983-03-01Manufacturing (CMC) · Supplement 13 · standardAP
1982-06-03Manufacturing (CMC) · Supplement 24 · standardAP
1982-05-25Labeling · Supplement 30AP
1982-04-16Manufacturing (CMC) · Supplement 22 · standardAP
1982-04-12Labeling · Supplement 29AP
1981-12-21Manufacturing (CMC) · Supplement 20 · standardAP
1981-11-20Manufacturing (CMC) · Supplement 26 · 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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