APPLICATION
NDA018587
TYPE
NDA
ORIGINAL APPROVAL
1982-09-07
LATEST ACTION
2001-11-27
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
WYTENSINDiscontinued
GUANABENZ ACETATE EQ 8MG BASE · TABLET · ORAL
WYTENSINDiscontinued
GUANABENZ ACETATE EQ 16MG BASE · TABLET · ORAL
WYTENSINDiscontinued
GUANABENZ ACETATE EQ 4MG BASE · TABLET · ORAL
Approval history
2001-11-27Labeling · Supplement 23 · standardAP
1997-07-23Labeling · Supplement 22 · standardAP
1991-07-31Labeling · Supplement 21 · standardAP
1989-04-11Manufacturing (CMC) · Supplement 17 · standardAP
1989-01-25Labeling · Supplement 20 · standardAP
1988-09-22Labeling · Supplement 19 · standardAP
1988-04-08Manufacturing (CMC) · Supplement 18 · standardAP
1987-04-29Labeling · Supplement 11 · standardAP
1986-10-22Labeling · Supplement 15 · standardAP
1986-04-18Manufacturing (CMC) · Supplement 12 · standardAP
1986-03-26Manufacturing (CMC) · Supplement 14 · standardAP
1986-02-04Manufacturing (CMC) · Supplement 13 · standardAP
1985-12-18Manufacturing (CMC) · Supplement 10 · standardAP
1985-10-18Labeling · Supplement 9 · standardAP
1984-09-26Manufacturing (CMC) · Supplement 6 · standardAP
1984-06-26Labeling · Supplement 5 · standardAP
1984-02-27Labeling · Supplement 4 · standardAP
1983-12-23Manufacturing (CMC) · Supplement 3 · standardAP
1983-06-21Manufacturing (CMC) · Supplement 2 · standardAP
1983-06-20Manufacturing (CMC) · Supplement 1 · standardAP
1982-09-07Type 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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