APPLICATION
ANDA083220
TYPE
ANDA
ORIGINAL APPROVAL
1977-05-19
LATEST ACTION
2024-02-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription, Discontinued
Products
OGEN 5 · ReferencePrescription
ESTROPIPATE 6MG · TABLET · ORAL
OGEN 1.25 · ReferenceDiscontinued
ESTROPIPATE 1.5MG · TABLET · ORAL
OGEN 2.5 · ReferenceDiscontinued
ESTROPIPATE 3MG · TABLET · ORAL
OGEN .625 · ReferenceDiscontinued
ESTROPIPATE 0.75MG · TABLET · ORAL
Approval history
2024-02-15Labeling · Supplement 45 · standardAP
2019-05-03Labeling · Supplement 44 · standardAP
2015-11-03Labeling · Supplement 42AP
2001-09-26Manufacturing (CMC) · Supplement 38AP
2001-09-26Manufacturing (CMC) · Supplement 39AP
1998-07-17Manufacturing (CMC) · Supplement 35AP
1998-04-20Manufacturing (CMC) · Supplement 37AP
1998-04-09Manufacturing (CMC) · Supplement 36AP
1997-09-23Manufacturing (CMC) · Supplement 34AP
1992-11-10Labeling · Supplement 24AP
1992-11-10Labeling · Supplement 47AP
1992-04-30Labeling · Supplement 25AP
1992-04-30Manufacturing (CMC) · Supplement 21AP
1992-04-30Manufacturing (CMC) · Supplement 20AP
1991-06-24Bioequivalence · Supplement 31AP
1987-06-01Manufacturing (CMC) · Supplement 22AP
1986-08-11Manufacturing (CMC) · Supplement 15AP
1985-11-26Manufacturing (CMC) · Supplement 12AP
1985-10-29Manufacturing (CMC) · Supplement 13AP
1985-10-29Manufacturing (CMC) · Supplement 9AP
1984-12-11Manufacturing (CMC) · Supplement 11AP
1984-05-04Manufacturing (CMC) · Supplement 10AP
1977-05-19OriginalAP
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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