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FDA ANDA · ANDA084499

ESTRACE

Sponsor: BRISTOL MYERS SQUIBB

APPLICATION
ANDA084499
TYPE
ANDA
ORIGINAL APPROVAL
1975-07-28
LATEST ACTION
2005-09-12
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ESTRACE · ReferenceDiscontinued
ESTRADIOL 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2005-09-12Labeling · Supplement 42 — Label ↗AP
2001-01-25Manufacturing (CMC) · Supplement 39AP
1998-10-05Labeling · Supplement 37AP
1997-07-28Manufacturing (CMC) · Supplement 36AP
1997-01-08Labeling · Supplement 35AP
1995-09-11Manufacturing (CMC) · Supplement 34AP
1995-01-19Manufacturing (CMC) · Supplement 33AP
1995-01-19Manufacturing (CMC) · Supplement 31AP
1995-01-19Manufacturing (CMC) · Supplement 32AP
1995-01-19Manufacturing (CMC) · Supplement 30AP
1994-05-09Labeling · Supplement 29AP
1993-01-12Labeling · Supplement 28AP
1992-11-09Labeling · Supplement 23AP
1992-11-09Manufacturing (CMC) · Supplement 24AP
1992-11-09Manufacturing (CMC) · Supplement 22AP
1992-09-08Labeling · Supplement 21AP
1992-08-10Labeling · Supplement 27AP
1989-06-30Manufacturing (CMC) · Supplement 26AP
1985-12-19Manufacturing (CMC) · Supplement 19AP
1983-03-10Manufacturing (CMC) · Supplement 13AP
1982-06-04Manufacturing (CMC) · Supplement 12AP
1975-07-28OriginalAP
VIEW ON DRUGS@FDA ↗

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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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