APPLICATION
NDA018080
TYPE
NDA
ORIGINAL APPROVAL
1979-08-28
LATEST ACTION
2025-06-09
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
DEXTROSE 10% IN PLASTIC CONTAINER · ReferencePrescription
DEXTROSE 10GM/100ML · INJECTABLE · INJECTION
Approval history
2014-09-08Manufacturing (CMC) · Supplement 115 · standardAP
2008-08-07Labeling · Supplement 99AP
2003-04-24Labeling · Supplement 84AP
2002-11-01Manufacturing (CMC) · Supplement 82 · standardAP
2002-07-24Labeling · Supplement 81AP
1999-03-31Labeling · Supplement 80AP
1998-12-01Manufacturing (CMC) · Supplement 79 · standardAP
1997-08-20Labeling · Supplement 77AP
1997-06-11Manufacturing (CMC) · Supplement 78 · standardAP
1997-03-28Manufacturing (CMC) · Supplement 76 · standardAP
1996-08-29Manufacturing (CMC) · Supplement 72 · standardAP
1996-08-27Manufacturing (CMC) · Supplement 71 · standardAP
1996-08-06Manufacturing (CMC) · Supplement 75 · standardAP
1996-03-04Manufacturing (CMC) · Supplement 74 · standardAP
1995-08-18Manufacturing (CMC) · Supplement 73 · standardAP
1995-08-14Manufacturing (CMC) · Supplement 69 · standardAP
1993-10-25Manufacturing (CMC) · Supplement 60 · standardAP
1993-10-25Labeling · Supplement 61AP
1992-01-28Manufacturing (CMC) · Supplement 65 · standardAP
1991-09-10Manufacturing (CMC) · Supplement 64 · standardAP
1991-08-30Manufacturing (CMC) · Supplement 66 · standardAP
1990-02-22Manufacturing (CMC) · Supplement 59 · standardAP
1990-01-11Manufacturing (CMC) · Supplement 62 · standardAP
1989-02-06Manufacturing (CMC) · Supplement 36 · standardAP
1986-11-26Manufacturing (CMC) · Supplement 56 · standardAP
1986-08-08Manufacturing (CMC) · Supplement 55 · standardAP
1986-06-25Labeling · Supplement 31AP
1986-06-25Manufacturing (CMC) · Supplement 30 · standardAP
1986-01-31Manufacturing (CMC) · Supplement 52 · standardAP
1985-11-29Labeling · Supplement 40AP
1985-11-29Manufacturing (CMC) · Supplement 39 · standardAP
1985-10-29Manufacturing (CMC) · Supplement 38 · standardAP
1985-10-26Manufacturing (CMC) · Supplement 48 · standardAP
1985-10-26Labeling · Supplement 50AP
1985-09-26Manufacturing (CMC) · Supplement 42 · standardAP
1985-06-10Manufacturing (CMC) · Supplement 54 · standardAP
1985-05-03Manufacturing (CMC) · Supplement 49 · standardAP
1985-03-11Manufacturing (CMC) · Supplement 43 · standardAP
1984-11-28Manufacturing (CMC) · Supplement 37 · 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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