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FDA ANDA · ANDA075740

TAMOXIFEN CITRATE

Sponsor: IVAX SUB TEVA PHARMS

APPLICATION
ANDA075740
TYPE
ANDA
ORIGINAL APPROVAL
2003-02-20
LATEST ACTION
2005-08-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

TAMOXIFEN CITRATEDiscontinued
TAMOXIFEN CITRATE EQ 10MG BASE · TABLET · ORAL
TAMOXIFEN CITRATEDiscontinued
TAMOXIFEN CITRATE EQ 20MG BASE · TABLET · ORAL

Approval history

2005-08-01Labeling · Supplement 7AP
2005-01-31Labeling · Supplement 6AP
2003-08-11Labeling · Supplement 3AP
2003-02-20OriginalAP
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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