APPLICATION
ANDA089582
TYPE
ANDA
ORIGINAL APPROVAL
1991-07-17
LATEST ACTION
2024-02-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ORTHO-ESTDiscontinued
ESTROPIPATE 1.5MG · TABLET · ORAL
Approval history
2024-02-16Labeling · Supplement 20 · standardAP
2004-07-21Labeling · Supplement 19AP
2003-08-26Labeling · Supplement 15AP
2003-06-11Labeling · Supplement 13AP
2002-03-19Manufacturing (CMC) · Supplement 10AP
2002-03-19Manufacturing (CMC) · Supplement 11AP
1998-06-12Manufacturing (CMC) · Supplement 8AP
1996-07-08Labeling · Supplement 6AP
1996-02-22Manufacturing (CMC) · Supplement 5AP
1995-05-04Manufacturing (CMC) · Supplement 4AP
1993-09-23Labeling · Supplement 3AP
1993-06-21Labeling · Supplement 2AP
1993-04-19Labeling · Supplement 1AP
1991-07-17OriginalAP
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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