APPLICATION
ANDA201893
TYPE
ANDA
ORIGINAL APPROVAL
2015-09-16
LATEST ACTION
2024-03-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
NADOLOLPrescription
NADOLOL 80MG · TABLET · ORAL
NADOLOLPrescription
NADOLOL 20MG · TABLET · ORAL
NADOLOLPrescription
NADOLOL 40MG · TABLET · ORAL
Approval history
2024-03-01Labeling · Supplement 7 · standardAP
2022-06-07Manufacturing (CMC) · Supplement 3 · unknownAP
2019-05-01Manufacturing (CMC) · Supplement 1AP
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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