APPLICATION
NDA018904
TYPE
NDA
ORIGINAL APPROVAL
2008-05-07
LATEST ACTION
2009-06-18
ROUTE
IRRIGATION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
UROLOGIC G IN PLASTIC CONTAINERDiscontinued
CITRIC ACID 3.24GM/100ML, MAGNESIUM OXIDE 380MG/100ML, SODIUM CARBONATE 430MG/100ML · SOLUTION · IRRIGATION
Approval history
2009-06-18Labeling · Supplement 13AP
2008-05-07Type 5 - New Formulation or New Manufacturer · Original · standardAP
2000-03-03Manufacturing (CMC) · Supplement 15 · standardAP
1998-02-10Manufacturing (CMC) · Supplement 14 · standardAP
1996-08-27Manufacturing (CMC) · Supplement 11 · standardAP
1996-04-22Manufacturing (CMC) · Supplement 12 · standardAP
1993-08-24Manufacturing (CMC) · Supplement 8 · standardAP
1992-06-30Manufacturing (CMC) · Supplement 9 · standardAP
1988-11-25Manufacturing (CMC) · Supplement 7 · standardAP
1986-01-18Manufacturing (CMC) · Supplement 4 · standardAP
1985-10-29Manufacturing (CMC) · Supplement 6 · standardAP
1984-10-22Manufacturing (CMC) · Supplement 3 · standardAP
1984-08-25Manufacturing (CMC) · Supplement 2 · standardAP
1984-03-15Manufacturing (CMC) · Supplement 1 · 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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