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FDA ANDA · ANDA040212

GYNODIOL

Sponsor: DURAMED PHARMS BARR

APPLICATION
ANDA040212
TYPE
ANDA
ORIGINAL APPROVAL
1997-12-29
LATEST ACTION
2002-12-12
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

GYNODIOLDiscontinued
ESTRADIOL 2MG · TABLET · ORAL
GYNODIOLDiscontinued
ESTRADIOL 1MG · TABLET · ORAL
GYNODIOLDiscontinued
ESTRADIOL 1.5MG · TABLET · ORAL
GYNODIOLDiscontinued
ESTRADIOL 0.5MG · TABLET · ORAL

Approval history

2002-12-12Manufacturing (CMC) · Supplement 6AP
2002-12-12Manufacturing (CMC) · Supplement 5AP
2002-06-19Manufacturing (CMC) · Supplement 4AP
2001-10-10Manufacturing (CMC) · Supplement 2AP
2000-05-16Manufacturing (CMC) · Supplement 3AP
1998-12-11Labeling · Supplement 1AP
1997-12-29OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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