APPLICATION
ANDA074267
TYPE
ANDA
ORIGINAL APPROVAL
1994-06-01
LATEST ACTION
1999-03-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
GUANABENZ ACETATEDiscontinued
GUANABENZ ACETATE EQ 8MG BASE · TABLET · ORAL
GUANABENZ ACETATEDiscontinued
GUANABENZ ACETATE EQ 4MG BASE · TABLET · ORAL
Approval history
1999-03-23Manufacturing (CMC) · Supplement 4AP
1998-06-12Labeling · Supplement 3AP
1996-05-31Manufacturing (CMC) · Supplement 2AP
1994-06-28Labeling · Supplement 1AP
1994-06-01OriginalAP
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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