APPLICATION
NDA019345
TYPE
NDA
ORIGINAL APPROVAL
1985-01-26
LATEST ACTION
2018-05-14
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
DEXTROSE 30% IN PLASTIC CONTAINER · ReferencePrescription
DEXTROSE 30GM/100ML · INJECTABLE · INJECTION
Approval history
2003-06-02Labeling · Supplement 30AP
2002-11-01Manufacturing (CMC) · Supplement 28 · standardAP
1999-05-27Labeling · Supplement 27AP
1998-12-01Manufacturing (CMC) · Supplement 26 · standardAP
1997-08-20Labeling · Supplement 24AP
1997-06-11Manufacturing (CMC) · Supplement 25 · standardAP
1997-03-28Manufacturing (CMC) · Supplement 23 · standardAP
1996-08-27Manufacturing (CMC) · Supplement 19 · standardAP
1996-08-06Manufacturing (CMC) · Supplement 22 · standardAP
1996-03-04Manufacturing (CMC) · Supplement 21 · standardAP
1995-08-18Manufacturing (CMC) · Supplement 20 · standardAP
1993-12-13Manufacturing (CMC) · Supplement 17 · standardAP
1993-01-21Manufacturing (CMC) · Supplement 15 · standardAP
1992-01-28Manufacturing (CMC) · Supplement 14 · standardAP
1991-09-10Manufacturing (CMC) · Supplement 13 · standardAP
1990-02-22Manufacturing (CMC) · Supplement 11 · standardAP
1990-01-11Manufacturing (CMC) · Supplement 12 · standardAP
1989-02-06Manufacturing (CMC) · Supplement 8 · standardAP
1987-02-13Labeling · Supplement 5AP
1987-02-13Manufacturing (CMC) · Supplement 4 · standardAP
1986-11-26Manufacturing (CMC) · Supplement 7 · standardAP
1986-08-29Manufacturing (CMC) · Supplement 3 · standardAP
1986-08-08Manufacturing (CMC) · Supplement 6 · standardAP
1986-01-31Manufacturing (CMC) · Supplement 1 · standardAP
1985-08-13Manufacturing (CMC) · Supplement 2 · standardAP
1985-01-26Type 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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