APPLICATION
ANDA040138
TYPE
ANDA
ORIGINAL APPROVAL
1998-01-30
LATEST ACTION
2000-12-21
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
2000-12-21Manufacturing (CMC) · Supplement 3AP
2000-12-21Manufacturing (CMC) · Supplement 2AP
2000-09-08Labeling · Supplement 4AP
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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