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FDA ANDA · ANDA075498

TERAZOSIN HYDROCHLORIDE

Sponsor: HIKMA

APPLICATION
ANDA075498
TYPE
ANDA
ORIGINAL APPROVAL
2001-04-12
LATEST ACTION
2006-06-07
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

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

Approval history

2006-06-07Labeling · Supplement 7AP
2002-10-01Labeling · Supplement 1AP
2001-04-12Original — Letter ↗AP
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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