APPLICATION
ANDA074255
TYPE
ANDA
ORIGINAL APPROVAL
1996-01-24
LATEST ACTION
2015-04-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
NADOLOLDiscontinued
NADOLOL 120MG · TABLET · ORAL
NADOLOLDiscontinued
NADOLOL 160MG · TABLET · ORAL
NADOLOLDiscontinued
NADOLOL 80MG · TABLET · ORAL
Approval history
2015-04-16Labeling · Supplement 18AP
2015-04-16Labeling · Supplement 16AP
2015-04-16Labeling · Supplement 19 · standardAP
2002-07-29Manufacturing (CMC) · Supplement 7AP
2002-03-12Manufacturing (CMC) · Supplement 6AP
2001-07-31Manufacturing (CMC) · Supplement 4AP
2000-01-28Manufacturing (CMC) · Supplement 3AP
1998-04-06Manufacturing (CMC) · Supplement 2AP
1998-04-06Manufacturing (CMC) · Supplement 1AP
1996-01-24OriginalAP
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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