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FDA ANDA · ANDA075667

TERAZOSIN

Sponsor: BIONPHARMA

APPLICATION
ANDA075667
TYPE
ANDA
ORIGINAL APPROVAL
2000-07-28
LATEST ACTION
2024-01-19
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

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

Approval history

2024-01-19Manufacturing (CMC) · Supplement 2 · unknownAP
2000-07-28OriginalLetterAP
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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