APPLICATION
ANDA040326
TYPE
ANDA
ORIGINAL APPROVAL
1999-04-21
LATEST ACTION
2024-02-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ESTRADIOLDiscontinued
ESTRADIOL 1MG · TABLET · ORAL
ESTRADIOLDiscontinued
ESTRADIOL 2MG · TABLET · ORAL
ESTRADIOLDiscontinued
ESTRADIOL 0.5MG · TABLET · ORAL
Approval history
2024-02-15Labeling · Supplement 16 · standardAP
2019-01-04Labeling · Supplement 14 · standardAP
2009-10-14Labeling · Supplement 8AP
2002-01-16Manufacturing (CMC) · Supplement 2AP
2001-11-29Manufacturing (CMC) · Supplement 1AP
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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