APPLICATION
NDA006110
TYPE
NDA
ORIGINAL APPROVAL
1947-01-09
LATEST ACTION
1988-04-01
ROUTE
VAGINAL
DOSAGE FORM
CREAM
MARKETING STATUS
Discontinued
Products
DIENESTROLDiscontinued
DIENESTROL 0.01% · CREAM · VAGINAL
Approval history
1988-04-01Manufacturing (CMC) · Supplement 27AP
1987-12-07Labeling · Supplement 28AP
1986-11-26Labeling · Supplement 26AP
1985-01-24Manufacturing (CMC) · Supplement 24AP
1984-06-01Manufacturing (CMC) · Supplement 23AP
1984-02-08Labeling · Supplement 21AP
1983-06-09Manufacturing (CMC) · Supplement 22AP
1982-07-08Manufacturing (CMC) · Supplement 20AP
1980-07-29Efficacy · Supplement 19AP
1980-04-25Efficacy · Supplement 17AP
1980-04-25Efficacy · Supplement 16AP
1980-04-25Manufacturing (CMC) · Supplement 14AP
1979-06-21Efficacy · Supplement 15AP
1978-04-17Manufacturing (CMC) · Supplement 11AP
1978-01-11Labeling · Supplement 12AP
1977-05-25Labeling · Supplement 8AP
1976-09-27Manufacturing (CMC) · Supplement 6AP
1976-03-10Labeling · Supplement 5AP
1947-01-09OriginalAP
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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