APPLICATION
ANDA040114
TYPE
ANDA
ORIGINAL APPROVAL
1996-03-14
LATEST ACTION
2024-02-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ESTRADIOLDiscontinued
ESTRADIOL 0.5MG · TABLET · ORAL
ESTRADIOLDiscontinued
ESTRADIOL 1MG · TABLET · ORAL
ESTRADIOLDiscontinued
ESTRADIOL 2MG · TABLET · ORAL
Approval history
2024-02-16Labeling · Supplement 28 · standardAP
2019-01-31Labeling · Supplement 25 · standardAP
2007-02-21Labeling · Supplement 13AP
2002-07-15Manufacturing (CMC) · Supplement 11AP
2002-07-15Manufacturing (CMC) · Supplement 10AP
2002-06-17Manufacturing (CMC) · Supplement 9AP
2001-09-05Manufacturing (CMC) · Supplement 8AP
2001-07-30Manufacturing (CMC) · Supplement 7AP
2001-06-20Manufacturing (CMC) · Supplement 6AP
2001-02-20Manufacturing (CMC) · Supplement 2AP
2000-08-01Manufacturing (CMC) · Supplement 5AP
1999-11-10Manufacturing (CMC) · Supplement 3AP
1999-10-13Labeling · Supplement 4AP
1996-03-14OriginalAP
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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