APPLICATION
ANDA074288
TYPE
ANDA
ORIGINAL APPROVAL
1995-04-24
LATEST ACTION
2014-03-28
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
ACEBUTOLOL HYDROCHLORIDEDiscontinued
ACEBUTOLOL HYDROCHLORIDE EQ 400MG BASE · CAPSULE · ORAL
ACEBUTOLOL HYDROCHLORIDEDiscontinued
ACEBUTOLOL HYDROCHLORIDE EQ 200MG BASE · CAPSULE · ORAL
Approval history
2014-03-28Manufacturing (CMC) · Supplement 10 · unknownAP
2014-03-26Labeling · Supplement 9 · standardAP
1999-11-04Labeling · Supplement 3AP
1998-06-23Labeling · Supplement 2AP
1998-02-05Manufacturing (CMC) · Supplement 1AP
1995-04-24OriginalAP
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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