APPLICATION
NDA019346
TYPE
NDA
ORIGINAL APPROVAL
1985-01-25
LATEST ACTION
2002-11-01
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
DEXTROSE 60% IN PLASTIC CONTAINERDiscontinued
DEXTROSE 60GM/100ML · INJECTABLE · INJECTION
Approval history
2002-11-01Manufacturing (CMC) · Supplement 29AP
1999-07-16Labeling · Supplement 28AP
1999-05-27Labeling · Supplement 27AP
1998-12-01Manufacturing (CMC) · Supplement 26AP
1997-08-20Labeling · Supplement 24AP
1997-06-11Manufacturing (CMC) · Supplement 25AP
1997-03-28Manufacturing (CMC) · Supplement 23AP
1996-08-27Manufacturing (CMC) · Supplement 19AP
1996-08-06Manufacturing (CMC) · Supplement 22AP
1996-03-04Manufacturing (CMC) · Supplement 21AP
1995-08-18Manufacturing (CMC) · Supplement 20AP
1993-12-13Manufacturing (CMC) · Supplement 17AP
1993-01-21Manufacturing (CMC) · Supplement 15AP
1992-01-28Manufacturing (CMC) · Supplement 14AP
1991-09-10Manufacturing (CMC) · Supplement 13AP
1990-02-22Manufacturing (CMC) · Supplement 11AP
1990-01-11Manufacturing (CMC) · Supplement 12AP
1989-02-06Manufacturing (CMC) · Supplement 8AP
1987-02-13Labeling · Supplement 5AP
1987-02-13Manufacturing (CMC) · Supplement 4AP
1986-11-26Manufacturing (CMC) · Supplement 7AP
1986-08-29Manufacturing (CMC) · Supplement 3AP
1986-08-13Manufacturing (CMC) · Supplement 2AP
1986-08-08Manufacturing (CMC) · Supplement 6AP
1986-01-31Manufacturing (CMC) · Supplement 1AP
1985-01-25Type 5 - New Formulation or New Manufacturer · Original · 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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