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FDA ANDA · ANDA074530

TERAZOSIN HYDROCHLORIDE

Sponsor: IVAX SUB TEVA PHARMS

APPLICATION
ANDA074530
TYPE
ANDA
ORIGINAL APPROVAL
2000-04-21
LATEST ACTION
2001-11-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

TERAZOSIN HYDROCHLORIDEDiscontinued
TERAZOSIN HYDROCHLORIDE EQ 5MG BASE · TABLET · ORAL
TERAZOSIN HYDROCHLORIDEDiscontinued
TERAZOSIN HYDROCHLORIDE EQ 1MG BASE · TABLET · ORAL
TERAZOSIN HYDROCHLORIDEDiscontinued
TERAZOSIN HYDROCHLORIDE EQ 10MG BASE · TABLET · ORAL
TERAZOSIN HYDROCHLORIDEDiscontinued
TERAZOSIN HYDROCHLORIDE EQ 2MG BASE · TABLET · ORAL

Approval history

2001-11-20Labeling · Supplement 5AP
2001-11-20Manufacturing (CMC) · Supplement 4AP
2001-10-22Manufacturing (CMC) · Supplement 3AP
2001-10-22Manufacturing (CMC) · Supplement 1AP
2001-10-22Manufacturing (CMC) · Supplement 2AP
2000-04-21OriginalLabelAP
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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