APPLICATION
ANDA074501
TYPE
ANDA
ORIGINAL APPROVAL
1995-11-09
LATEST ACTION
2024-05-06
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
NADOLOLPrescription
NADOLOL 40MG · TABLET · ORAL
NADOLOLPrescription
NADOLOL 80MG · TABLET · ORAL
NADOLOLPrescription
NADOLOL 20MG · TABLET · ORAL
Approval history
2024-05-06Labeling · Supplement 13 · standardAP
2015-06-13Labeling · Supplement 6AP
2008-07-29Labeling · Supplement 4AP
2000-01-03Manufacturing (CMC) · Supplement 1AP
2000-01-03Manufacturing (CMC) · Supplement 2AP
1995-11-09OriginalAP
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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