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FDA ANDA · ANDA040135

ESTROPIPATE

Sponsor: BARR

APPLICATION
ANDA040135
TYPE
ANDA
ORIGINAL APPROVAL
1996-11-27
LATEST ACTION
2002-04-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ESTROPIPATEDiscontinued
ESTROPIPATE 1.5MG · TABLET · ORAL
ESTROPIPATEDiscontinued
ESTROPIPATE 3MG · TABLET · ORAL
ESTROPIPATEDiscontinued
ESTROPIPATE 0.75MG · TABLET · ORAL

Approval history

2002-04-03Manufacturing (CMC) · Supplement 9AP
2000-05-23Manufacturing (CMC) · Supplement 8AP
1999-12-21Manufacturing (CMC) · Supplement 7AP
1999-07-06Manufacturing (CMC) · Supplement 6AP
1999-05-20Manufacturing (CMC) · Supplement 5AP
1998-12-01Manufacturing (CMC) · Supplement 4AP
1998-10-20Manufacturing (CMC) · Supplement 3AP
1998-08-26Manufacturing (CMC) · Supplement 2AP
1997-04-09Labeling · Supplement 1AP
1996-11-27OriginalAP
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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