APPLICATION
NDA019057
TYPE
NDA
ORIGINAL APPROVAL
1987-08-07
LATEST ACTION
2009-07-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
HYTRINDiscontinued
TERAZOSIN HYDROCHLORIDE EQ 10MG BASE · TABLET · ORAL
HYTRINDiscontinued
TERAZOSIN HYDROCHLORIDE EQ 2MG BASE · TABLET · ORAL
HYTRINDiscontinued
TERAZOSIN HYDROCHLORIDE EQ 5MG BASE · TABLET · ORAL
HYTRINDiscontinued
TERAZOSIN HYDROCHLORIDE EQ 1MG BASE · TABLET · ORAL
Approval history
2002-12-24Manufacturing (CMC) · Supplement 18 · standardAP
2002-11-15Manufacturing (CMC) · Supplement 17 · standardAP
2002-10-04Manufacturing (CMC) · Supplement 16 · standardAP
1998-08-06Manufacturing (CMC) · Supplement 14 · standardAP
1998-04-16Manufacturing (CMC) · Supplement 13 · standardAP
1996-09-18Labeling · Supplement 11 · standardAP
1996-08-08Manufacturing (CMC) · Supplement 12 · standardAP
1995-10-06Manufacturing (CMC) · Supplement 9 · standardAP
1995-07-11Manufacturing (CMC) · Supplement 10 · standardAP
1994-09-14Labeling · Supplement 8 · standardAP
1994-06-17Manufacturing (CMC) · Supplement 7 · standardAP
1993-09-29Labeling · Supplement 6 · standardAP
1993-08-20Manufacturing (CMC) · Supplement 5 · standardAP
1991-08-09Manufacturing (CMC) · Supplement 4 · standardAP
1990-08-10Labeling · Supplement 3 · standardAP
1988-09-20Manufacturing (CMC) · Supplement 2 · standardAP
1988-07-01Labeling · Supplement 1 · standardAP
1987-08-07Type 1 - New Molecular Entity · Original · standardAP
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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