APPLICATION
ANDA074172
TYPE
ANDA
ORIGINAL APPROVAL
1993-10-31
LATEST ACTION
2024-08-23
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
2024-08-23Labeling · Supplement 19 · standardAP
2015-06-25Labeling · Supplement 14 · standardAP
2015-06-25Labeling · Supplement 15 · standardAP
2010-05-10Labeling · Supplement 13AP
2000-08-16Manufacturing (CMC) · Supplement 2AP
1998-02-05Manufacturing (CMC) · Supplement 1AP
1993-10-31OriginalAP
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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