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FDA ANDA · ANDA074315

TERAZOSIN HYDROCHLORIDE

Sponsor: SANDOZ

APPLICATION
ANDA074315
TYPE
ANDA
ORIGINAL APPROVAL
1998-12-31
LATEST ACTION
2003-06-13
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

2003-06-13Labeling · Supplement 11AP
2002-04-19Manufacturing (CMC) · Supplement 8AP
2002-03-05Manufacturing (CMC) · Supplement 9AP
2001-09-04Manufacturing (CMC) · Supplement 7AP
2001-04-25Manufacturing (CMC) · Supplement 6AP
2000-04-06Manufacturing (CMC) · Supplement 2AP
2000-04-06Labeling · Supplement 3AP
2000-02-22Manufacturing (CMC) · Supplement 5AP
1999-07-07Manufacturing (CMC) · Supplement 4AP
1999-07-07Manufacturing (CMC) · Supplement 1AP
1998-12-31Original — Label ↗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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