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FDA ANDA · ANDA074149

GUANABENZ ACETATE

Sponsor: ANI PHARMS

APPLICATION
ANDA074149
TYPE
ANDA
ORIGINAL APPROVAL
1995-04-07
LATEST ACTION
2002-07-29
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

2002-07-29Manufacturing (CMC) · Supplement 9AP
2002-03-12Manufacturing (CMC) · Supplement 8AP
2000-01-28Manufacturing (CMC) · Supplement 6AP
1999-05-27Labeling · Supplement 5AP
1999-05-27Labeling · Supplement 4AP
1995-07-14Manufacturing (CMC) · Supplement 3AP
1995-07-14Manufacturing (CMC) · Supplement 1AP
1995-07-14Labeling · Supplement 2AP
1995-04-07OriginalAP
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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