APPLICATION
NDA016678
TYPE
NDA
ORIGINAL APPROVAL
1970-12-09
LATEST ACTION
2019-08-22
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
DEXTROSE 5% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERPrescription
DEXTROSE 5GM/100ML, SODIUM CHLORIDE 900MG/100ML · INJECTABLE · INJECTION
Approval history
2015-12-23Manufacturing (CMC) · Supplement 108 · standardAP
2015-01-12Manufacturing (CMC) · Supplement 106 · standardAP
2001-08-14Manufacturing (CMC) · Supplement 96 · standardAP
2000-11-29Labeling · Supplement 94 · standardAP
1999-11-24Manufacturing (CMC) · Supplement 95 · standardAP
1997-04-29Manufacturing (CMC) · Supplement 93 · standardAP
1996-10-11Manufacturing (CMC) · Supplement 92 · standardAP
1994-09-30Manufacturing (CMC) · Supplement 90 · standardAP
1994-02-18Manufacturing (CMC) · Supplement 91 · standardAP
1991-04-29Manufacturing (CMC) · Supplement 87 · standardAP
1991-03-26Manufacturing (CMC) · Supplement 86 · standardAP
1991-02-15Manufacturing (CMC) · Supplement 85 · standardAP
1989-07-26Manufacturing (CMC) · Supplement 84 · standardAP
1989-01-12Manufacturing (CMC) · Supplement 83 · standardAP
1987-07-25Manufacturing (CMC) · Supplement 82 · standardAP
1987-05-28Manufacturing (CMC) · Supplement 81 · standardAP
1986-02-27Manufacturing (CMC) · Supplement 78 · standardAP
1985-08-28Manufacturing (CMC) · Supplement 69 · standardAP
1985-08-28Manufacturing (CMC) · Supplement 70 · standardAP
1985-07-03Labeling · Supplement 76AP
1985-06-13Manufacturing (CMC) · Supplement 74 · standardAP
1985-04-15Manufacturing (CMC) · Supplement 77 · standardAP
1985-01-24Manufacturing (CMC) · Supplement 67 · standardAP
1984-09-22Manufacturing (CMC) · Supplement 73 · standardAP
1984-03-16Manufacturing (CMC) · Supplement 68 · standardAP
1984-02-28Manufacturing (CMC) · Supplement 72 · standardAP
1983-07-11Labeling · Supplement 64AP
1982-06-03Manufacturing (CMC) · Supplement 61 · standardAP
1982-04-16Manufacturing (CMC) · Supplement 59 · standardAP
1982-02-16Manufacturing (CMC) · Supplement 65 · standardAP
1981-12-21Manufacturing (CMC) · Supplement 57 · standardAP
1981-11-20Manufacturing (CMC) · Supplement 63 · standardAP
1981-11-09Manufacturing (CMC) · Supplement 60 · standardAP
1981-08-26Labeling · Supplement 58AP
1981-06-29Manufacturing (CMC) · Supplement 54 · standardAP
1981-05-08Manufacturing (CMC) · Supplement 56 · standardAP
1981-04-16Manufacturing (CMC) · Supplement 50 · 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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