APPLICATION
NDA017521
TYPE
NDA
ORIGINAL APPROVAL
1979-08-28
LATEST ACTION
2018-03-14
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
DEXTROSE 70% IN PLASTIC CONTAINER · ReferenceDiscontinued
DEXTROSE 70GM/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
DEXTROSE 20% IN PLASTIC CONTAINER · ReferenceDiscontinued
DEXTROSE 20GM/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
DEXTROSE 40% IN PLASTIC CONTAINER · ReferenceDiscontinued
DEXTROSE 40GM/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
DEXTROSE 60% IN PLASTIC CONTAINER · ReferenceDiscontinued
DEXTROSE 60GM/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
DEXTROSE 30% IN PLASTIC CONTAINER · ReferenceDiscontinued
DEXTROSE 30GM/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
DEXTROSE 50% IN PLASTIC CONTAINER · ReferenceDiscontinued
DEXTROSE 50GM/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
2016-03-23Manufacturing (CMC) · Supplement 72 · standardAP
2016-01-15Manufacturing (CMC) · Supplement 71 · standardAP
2015-02-03Manufacturing (CMC) · Supplement 70 · standardAP
2001-08-14Manufacturing (CMC) · Supplement 64 · standardAP
2000-12-07Efficacy · Supplement 61 · standardAP
1999-11-24Manufacturing (CMC) · Supplement 60 · standardAP
1999-05-25Manufacturing (CMC) · Supplement 59 · standardAP
1998-06-22Manufacturing (CMC) · Supplement 58 · standardAP
1997-04-29Manufacturing (CMC) · Supplement 57 · standardAP
1995-01-05Labeling · Supplement 50AP
1995-01-05Manufacturing (CMC) · Supplement 49 · standardAP
1994-09-30Manufacturing (CMC) · Supplement 55 · standardAP
1994-02-18Manufacturing (CMC) · Supplement 56 · standardAP
1993-07-13Manufacturing (CMC) · Supplement 52 · standardAP
1991-03-26Manufacturing (CMC) · Supplement 51 · standardAP
1991-02-15Manufacturing (CMC) · Supplement 47 · standardAP
1990-05-18Manufacturing (CMC) · Supplement 48 · standardAP
1989-07-26Manufacturing (CMC) · Supplement 42 · standardAP
1989-01-12Manufacturing (CMC) · Supplement 41 · standardAP
1987-12-09Manufacturing (CMC) · Supplement 39 · standardAP
1985-06-13Manufacturing (CMC) · Supplement 35 · standardAP
1985-04-23Labeling · Supplement 38AP
1985-04-15Manufacturing (CMC) · Supplement 37 · standardAP
1985-01-24Manufacturing (CMC) · Supplement 27 · standardAP
1984-09-22Manufacturing (CMC) · Supplement 34 · standardAP
1984-09-21Manufacturing (CMC) · Supplement 36 · standardAP
1984-08-24Labeling · Supplement 33AP
1984-03-16Manufacturing (CMC) · Supplement 28 · standardAP
1984-02-28Manufacturing (CMC) · Supplement 32 · standardAP
1982-06-03Manufacturing (CMC) · Supplement 22 · standardAP
1982-04-16Manufacturing (CMC) · Supplement 18 · standardAP
1982-03-26Labeling · Supplement 15AP
1982-03-26Manufacturing (CMC) · Supplement 14 · standardAP
1982-02-16Manufacturing (CMC) · Supplement 25 · standardAP
1981-12-21Manufacturing (CMC) · Supplement 16 · standardAP
1981-11-20Manufacturing (CMC) · Supplement 24 · 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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