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FDA ANDA · ANDA074823

TERAZOSIN HYDROCHLORIDE

Sponsor: SENORES PHARMS

APPLICATION
ANDA074823
TYPE
ANDA
ORIGINAL APPROVAL
1998-03-30
LATEST ACTION
2024-12-12
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

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

Approval history

2024-12-12Manufacturing (CMC) · Supplement 28 · unknownAP
2007-08-09Labeling · Supplement 15AP
2002-10-01Labeling · Supplement 11AP
2002-04-19Manufacturing (CMC) · Supplement 8AP
2002-03-05Manufacturing (CMC) · Supplement 9AP
2001-11-06Manufacturing (CMC) · Supplement 7AP
2001-06-07Manufacturing (CMC) · Supplement 6AP
2000-06-28Manufacturing (CMC) · Supplement 5AP
1999-09-07Manufacturing (CMC) · Supplement 2AP
1999-09-07Labeling · Supplement 3AP
1999-06-18Manufacturing (CMC) · Supplement 4AP
1999-06-18Manufacturing (CMC) · Supplement 1AP
1998-03-30Original — Review ↗AP
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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