APPLICATION
NDA019466
TYPE
NDA
ORIGINAL APPROVAL
1985-07-15
LATEST ACTION
2025-06-06
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
DEXTROSE 5% IN PLASTIC CONTAINER · ReferencePrescription
DEXTROSE 5GM/100ML · INJECTABLE · INJECTION
Approval history
2019-05-29Manufacturing (CMC) · Supplement 62AP
2002-11-01Manufacturing (CMC) · Supplement 40 · standardAP
2000-04-06Manufacturing (CMC) · Supplement 39 · standardAP
2000-04-06Manufacturing (CMC) · Supplement 37 · standardAP
2000-04-06Labeling · Supplement 38AP
1999-03-31Labeling · Supplement 36AP
1998-12-01Manufacturing (CMC) · Supplement 35 · standardAP
1997-08-20Manufacturing (CMC) · Supplement 34 · standardAP
1997-08-20Labeling · Supplement 32AP
1997-06-11Manufacturing (CMC) · Supplement 33 · standardAP
1996-08-27Manufacturing (CMC) · Supplement 28 · standardAP
1996-03-04Manufacturing (CMC) · Supplement 31 · standardAP
1996-01-24Manufacturing (CMC) · Supplement 27 · standardAP
1995-08-18Manufacturing (CMC) · Supplement 30 · standardAP
1995-05-31Manufacturing (CMC) · Supplement 29 · standardAP
1995-01-05Manufacturing (CMC) · Supplement 25 · standardAP
1994-09-23Manufacturing (CMC) · Supplement 26 · standardAP
1994-02-25Manufacturing (CMC) · Supplement 24 · standardAP
1993-02-16Labeling · Supplement 16AP
1992-01-28Manufacturing (CMC) · Supplement 18 · standardAP
1991-12-30Manufacturing (CMC) · Supplement 21 · standardAP
1991-09-10Manufacturing (CMC) · Supplement 17 · standardAP
1990-11-02Manufacturing (CMC) · Supplement 15 · standardAP
1990-03-09Manufacturing (CMC) · Supplement 14 · standardAP
1990-02-22Manufacturing (CMC) · Supplement 12 · standardAP
1990-01-11Manufacturing (CMC) · Supplement 13 · standardAP
1989-09-20Labeling · Supplement 9AP
1989-08-03Manufacturing (CMC) · Supplement 11 · standardAP
1989-07-18Manufacturing (CMC) · Supplement 10 · standardAP
1989-02-06Manufacturing (CMC) · Supplement 6 · standardAP
1986-11-26Manufacturing (CMC) · Supplement 5 · standardAP
1986-08-11Manufacturing (CMC) · Supplement 4 · standardAP
1986-08-08Manufacturing (CMC) · Supplement 3 · standardAP
1986-05-27Manufacturing (CMC) · Supplement 2 · standardAP
1986-01-17Labeling · Supplement 1AP
1985-07-15Type 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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