APPLICATION
ANDA084710
TYPE
ANDA
ORIGINAL APPROVAL
1977-06-03
LATEST ACTION
2015-11-03
ROUTE
VAGINAL
DOSAGE FORM
CREAM
MARKETING STATUS
Discontinued
Products
OGENDiscontinued
ESTROPIPATE 1.5MG/GM · CREAM · VAGINAL
Approval history
2015-11-03Labeling · Supplement 22AP
1998-04-01Manufacturing (CMC) · Supplement 20AP
1996-09-24Manufacturing (CMC) · Supplement 19AP
1994-02-16Labeling · Supplement 18AP
1991-04-02Manufacturing (CMC) · Supplement 16AP
1991-04-02Manufacturing (CMC) · Supplement 17AP
1987-08-17Manufacturing (CMC) · Supplement 12AP
1984-01-03Manufacturing (CMC) · Supplement 10AP
1977-06-03OriginalAP
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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