APPLICATION
NDA016772
TYPE
NDA
ORIGINAL APPROVAL
1978-02-10
LATEST ACTION
2014-11-16
ROUTE
IRRIGATION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
RESECTISOL IN PLASTIC CONTAINERDiscontinued
MANNITOL 5GM/100ML · SOLUTION · IRRIGATION
Approval history
2014-11-16Manufacturing (CMC) · Supplement 34 · standardAP
2003-01-16Labeling · Supplement 30AP
2002-09-03Manufacturing (CMC) · Supplement 28 · standardAP
2002-04-10Manufacturing (CMC) · Supplement 27 · standardAP
1998-05-27Manufacturing (CMC) · Supplement 26 · standardAP
1990-09-11Manufacturing (CMC) · Supplement 25 · standardAP
1988-04-19Manufacturing (CMC) · Supplement 23 · standardAP
1987-03-05Manufacturing (CMC) · Supplement 19 · standardAP
1985-08-30Manufacturing (CMC) · Supplement 21 · standardAP
1985-07-27Labeling · Supplement 20AP
1985-05-24Manufacturing (CMC) · Supplement 16 · standardAP
1985-05-17Manufacturing (CMC) · Supplement 17 · standardAP
1985-04-03Manufacturing (CMC) · Supplement 18 · standardAP
1983-02-22Labeling · Supplement 15AP
1981-11-06Manufacturing (CMC) · Supplement 12 · standardAP
1981-10-27Labeling · Supplement 11AP
1981-10-27Manufacturing (CMC) · Supplement 10 · standardAP
1980-07-16Manufacturing (CMC) · Supplement 9 · standardAP
1980-02-15Manufacturing (CMC) · Supplement 8 · standardAP
1979-09-25Labeling · Supplement 7AP
1979-09-24Manufacturing (CMC) · Supplement 6 · standardAP
1979-08-17Labeling · Supplement 3AP
1979-07-20Labeling · Supplement 5AP
1979-04-26Manufacturing (CMC) · Supplement 4 · standardAP
1978-08-28Manufacturing (CMC) · Supplement 2 · standardAP
1978-08-07Manufacturing (CMC) · Supplement 1 · standardAP
1978-02-10Type 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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