APPLICATION
NDA019518
TYPE
NDA
ORIGINAL APPROVAL
1986-08-06
LATEST ACTION
1992-03-10
ROUTE
DENTAL
DOSAGE FORM
GEL, PASTE
MARKETING STATUS
Discontinued
Products
EXTRA-STRENGTH AIMDiscontinued
SODIUM MONOFLUOROPHOSPHATE 1.2% · GEL · DENTAL
EXTRA-STRENGTH AIMDiscontinued
SODIUM MONOFLUOROPHOSPHATE 1.2% · PASTE · DENTAL
Approval history
1992-03-10Manufacturing (CMC) · Supplement 6 · standardAP
1992-03-10Manufacturing (CMC) · Supplement 7 · standardAP
1989-01-24Labeling · Supplement 15 · standardAP
1988-12-09Labeling · Supplement 10 · standardAP
1988-06-21Manufacturing (CMC) · Supplement 8 · standardAP
1987-08-03Labeling · Supplement 4 · standardAP
1987-08-03Manufacturing (CMC) · Supplement 3 · standardAP
1987-06-03Labeling · Supplement 2 · standardAP
1987-06-03Manufacturing (CMC) · Supplement 1 · standardAP
1986-08-06Type 3 - New Dosage Form · 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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