APPLICATION
NDA018063
TYPE
NDA
ORIGINAL APPROVAL
1979-12-10
LATEST ACTION
2023-12-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
CORGARDDiscontinued
NADOLOL 160MG · TABLET · ORAL
CORGARD · ReferenceDiscontinued
NADOLOL 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
CORGARD · ReferenceDiscontinued
NADOLOL 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
CORGARDDiscontinued
NADOLOL 120MG · TABLET · ORAL
CORGARD · ReferenceDiscontinued
NADOLOL 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
2001-09-19Manufacturing (CMC) · Supplement 58 · standardAP
1996-03-18Manufacturing (CMC) · Supplement 57 · standardAP
1995-08-16Manufacturing (CMC) · Supplement 56 · standardAP
1994-04-05Manufacturing (CMC) · Supplement 55 · standardAP
1992-05-20Manufacturing (CMC) · Supplement 53 · standardAP
1992-05-01Manufacturing (CMC) · Supplement 54 · standardAP
1991-11-08Manufacturing (CMC) · Supplement 52 · standardAP
1991-05-03Manufacturing (CMC) · Supplement 51 · standardAP
1991-03-29Manufacturing (CMC) · Supplement 50 · standardAP
1990-11-07Labeling · Supplement 49AP
1990-08-21Manufacturing (CMC) · Supplement 47 · standardAP
1987-09-03Manufacturing (CMC) · Supplement 48 · standardAP
1987-03-11Manufacturing (CMC) · Supplement 45 · standardAP
1987-01-06Manufacturing (CMC) · Supplement 46 · standardAP
1986-10-28Efficacy · Supplement 35AP
1986-10-07Manufacturing (CMC) · Supplement 42 · standardAP
1986-08-19Manufacturing (CMC) · Supplement 43 · standardAP
1985-05-15Labeling · Supplement 40AP
1984-11-16Efficacy · Supplement 30AP
1984-10-24Manufacturing (CMC) · Supplement 39 · standardAP
1984-08-06Manufacturing (CMC) · Supplement 38 · standardAP
1984-05-16Manufacturing (CMC) · Supplement 34 · standardAP
1984-05-16Manufacturing (CMC) · Supplement 37 · standardAP
1984-05-15Manufacturing (CMC) · Supplement 36 · standardAP
1984-03-06Manufacturing (CMC) · Supplement 33 · standardAP
1984-02-08Manufacturing (CMC) · Supplement 32 · standardAP
1984-01-17Manufacturing (CMC) · Supplement 31 · standardAP
1983-11-01Manufacturing (CMC) · Supplement 29 · standardAP
1983-10-14Manufacturing (CMC) · Supplement 28 · standardAP
1983-07-21Manufacturing (CMC) · Supplement 27 · standardAP
1983-03-29Manufacturing (CMC) · Supplement 26 · standardAP
1983-03-29Manufacturing (CMC) · Supplement 24 · standardAP
1982-11-18Manufacturing (CMC) · Supplement 23 · standardAP
1982-10-01Manufacturing (CMC) · Supplement 21 · standardAP
1982-09-22Manufacturing (CMC) · Supplement 22 · standardAP
1982-06-02Manufacturing (CMC) · Supplement 19 · 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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