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FDA ANDA · ANDA081295

ESTRACE

Sponsor: BRISTOL MYERS SQUIBB

APPLICATION
ANDA081295
TYPE
ANDA
ORIGINAL APPROVAL
1993-06-30
LATEST ACTION
2005-09-12
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ESTRACEDiscontinued
ESTRADIOL 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2005-09-12Labeling · Supplement 14 — Label ↗AP
2001-01-25Manufacturing (CMC) · Supplement 11AP
1998-10-05Labeling · Supplement 9AP
1997-07-28Manufacturing (CMC) · Supplement 8AP
1997-01-08Labeling · Supplement 7AP
1997-01-07Labeling · Supplement 3AP
1997-01-07Manufacturing (CMC) · Supplement 2AP
1995-10-27Manufacturing (CMC) · Supplement 6AP
1995-06-06Manufacturing (CMC) · Supplement 5AP
1995-02-02Manufacturing (CMC) · Supplement 4AP
1994-05-09Labeling · Supplement 1AP
1993-06-30OriginalAP
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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