APPLICATION
NDA018917
TYPE
NDA
ORIGINAL APPROVAL
1984-12-28
LATEST ACTION
2011-03-03
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
SECTRAL · ReferenceDiscontinued
ACEBUTOLOL HYDROCHLORIDE EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
SECTRAL · ReferenceDiscontinued
ACEBUTOLOL HYDROCHLORIDE EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
Approval history
2001-07-13Manufacturing (CMC) · Supplement 21 · standardAP
1999-08-22Labeling · Supplement 20 · standardAP
1997-11-07Labeling · Supplement 19 · standardAP
1989-08-10Labeling · Supplement 17AP
1989-03-24Manufacturing (CMC) · Supplement 14 · standardAP
1988-12-05Labeling · Supplement 15AP
1988-12-05Manufacturing (CMC) · Supplement 10 · standardAP
1988-10-03Manufacturing (CMC) · Supplement 16 · standardAP
1987-12-18Manufacturing (CMC) · Supplement 13 · standardAP
1987-11-20Manufacturing (CMC) · Supplement 11 · standardAP
1987-08-18Manufacturing (CMC) · Supplement 12 · standardAP
1987-06-11Labeling · Supplement 7AP
1987-05-04Labeling · Supplement 8AP
1986-06-25Labeling · Supplement 6AP
1986-06-09Manufacturing (CMC) · Supplement 4 · standardAP
1985-08-28Manufacturing (CMC) · Supplement 2 · standardAP
1985-02-06Labeling · Supplement 1AP
1984-12-28Type 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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