APPLICATION
ANDA040359
TYPE
ANDA
ORIGINAL APPROVAL
1999-08-26
LATEST ACTION
2024-02-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ESTROPIPATEDiscontinued
ESTROPIPATE 3MG · TABLET · ORAL
ESTROPIPATEDiscontinued
ESTROPIPATE 0.75MG · TABLET · ORAL
ESTROPIPATEDiscontinued
ESTROPIPATE 1.5MG · TABLET · ORAL
Approval history
2024-02-15Labeling · Supplement 6 · standardAP
2009-10-16Labeling · Supplement 4AP
2002-04-19Manufacturing (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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