APPLICATION
NDA018564
TYPE
NDA
ORIGINAL APPROVAL
1982-03-23
LATEST ACTION
2018-05-14
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
DEXTROSE 20% IN PLASTIC CONTAINER · ReferencePrescription
DEXTROSE 20GM/100ML · INJECTABLE · INJECTION
Approval history
2003-09-11Labeling · Supplement 42AP
2002-11-01Manufacturing (CMC) · Supplement 40 · standardAP
1999-05-27Labeling · Supplement 38AP
1998-12-01Manufacturing (CMC) · Supplement 37 · standardAP
1997-08-20Labeling · Supplement 35AP
1997-06-11Manufacturing (CMC) · Supplement 36 · standardAP
1997-03-28Manufacturing (CMC) · Supplement 34 · standardAP
1996-08-27Manufacturing (CMC) · Supplement 30 · standardAP
1996-08-06Manufacturing (CMC) · Supplement 33 · standardAP
1996-03-04Manufacturing (CMC) · Supplement 32 · standardAP
1995-08-18Manufacturing (CMC) · Supplement 31 · standardAP
1993-12-13Manufacturing (CMC) · Supplement 28 · standardAP
1993-01-21Manufacturing (CMC) · Supplement 26 · standardAP
1992-01-28Manufacturing (CMC) · Supplement 25 · standardAP
1991-09-10Manufacturing (CMC) · Supplement 24 · standardAP
1990-02-22Manufacturing (CMC) · Supplement 22 · standardAP
1990-01-11Manufacturing (CMC) · Supplement 23 · standardAP
1989-02-06Manufacturing (CMC) · Supplement 9 · standardAP
1986-11-26Manufacturing (CMC) · Supplement 19 · standardAP
1986-08-08Manufacturing (CMC) · Supplement 18 · standardAP
1986-06-25Labeling · Supplement 5AP
1986-06-25Manufacturing (CMC) · Supplement 4 · standardAP
1986-01-31Manufacturing (CMC) · Supplement 17 · standardAP
1985-10-29Manufacturing (CMC) · Supplement 11 · standardAP
1985-09-26Manufacturing (CMC) · Supplement 13 · standardAP
1985-03-11Manufacturing (CMC) · Supplement 14 · standardAP
1984-11-28Manufacturing (CMC) · Supplement 10 · standardAP
1984-10-22Manufacturing (CMC) · Supplement 15 · standardAP
1984-10-17Manufacturing (CMC) · Supplement 7 · standardAP
1984-09-08Manufacturing (CMC) · Supplement 16 · standardAP
1984-03-21Manufacturing (CMC) · Supplement 6 · standardAP
1984-03-01Manufacturing (CMC) · Supplement 1 · standardAP
1984-02-17Manufacturing (CMC) · Supplement 3 · standardAP
1984-01-17Manufacturing (CMC) · Supplement 8 · standardAP
1982-07-26Manufacturing (CMC) · Supplement 2 · standardAP
1982-03-23Type 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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