APPLICATION
NDA016697
TYPE
NDA
ORIGINAL APPROVAL
1971-03-22
LATEST ACTION
2019-08-22
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER · ReferencePrescription
DEXTROSE 2.5GM/100ML, SODIUM CHLORIDE 450MG/100ML · INJECTABLE · INJECTION
Approval history
2014-08-29Manufacturing (CMC) · Supplement 97 · standardAP
2004-06-02Labeling · Supplement 91 · standardAP
2001-08-14Manufacturing (CMC) · Supplement 89 · standardAP
2000-11-29Labeling · Supplement 87 · standardAP
1999-11-24Manufacturing (CMC) · Supplement 88 · standardAP
1997-04-29Manufacturing (CMC) · Supplement 86 · standardAP
1994-09-30Manufacturing (CMC) · Supplement 84 · standardAP
1994-02-18Manufacturing (CMC) · Supplement 85 · standardAP
1991-04-29Manufacturing (CMC) · Supplement 81 · standardAP
1991-03-26Manufacturing (CMC) · Supplement 80 · standardAP
1991-02-25Manufacturing (CMC) · Supplement 82 · standardAP
1991-02-15Manufacturing (CMC) · Supplement 79 · standardAP
1989-07-26Manufacturing (CMC) · Supplement 78 · standardAP
1989-01-12Manufacturing (CMC) · Supplement 77 · standardAP
1987-07-25Manufacturing (CMC) · Supplement 76 · standardAP
1987-05-28Manufacturing (CMC) · Supplement 75 · standardAP
1986-02-27Manufacturing (CMC) · Supplement 73 · standardAP
1985-08-28Manufacturing (CMC) · Supplement 64 · standardAP
1985-08-28Manufacturing (CMC) · Supplement 65 · standardAP
1985-07-03Labeling · Supplement 71AP
1985-06-13Manufacturing (CMC) · Supplement 69 · standardAP
1985-04-15Manufacturing (CMC) · Supplement 72 · standardAP
1985-01-24Manufacturing (CMC) · Supplement 62 · standardAP
1984-09-22Manufacturing (CMC) · Supplement 68 · standardAP
1984-03-16Manufacturing (CMC) · Supplement 63 · standardAP
1984-02-28Manufacturing (CMC) · Supplement 67 · standardAP
1983-07-11Labeling · Supplement 59AP
1982-06-03Manufacturing (CMC) · Supplement 56 · standardAP
1982-04-16Manufacturing (CMC) · Supplement 54 · standardAP
1982-02-16Manufacturing (CMC) · Supplement 60 · standardAP
1981-12-21Manufacturing (CMC) · Supplement 52 · standardAP
1981-11-20Manufacturing (CMC) · Supplement 58 · standardAP
1981-11-09Manufacturing (CMC) · Supplement 55 · standardAP
1981-08-26Labeling · Supplement 53AP
1981-06-29Manufacturing (CMC) · Supplement 50 · standardAP
1981-04-16Manufacturing (CMC) · Supplement 46 · standardAP
1981-01-21Manufacturing (CMC) · Supplement 49 · standardAP
1980-08-07Manufacturing (CMC) · Supplement 42 · 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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