APPLICATION
ANDA076140
TYPE
ANDA
ORIGINAL APPROVAL
2002-09-26
LATEST ACTION
2023-09-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
SOTALOL HYDROCHLORIDEPrescription
SOTALOL HYDROCHLORIDE 240MG · TABLET · ORAL
SOTALOL HYDROCHLORIDEPrescription
SOTALOL HYDROCHLORIDE 120MG · TABLET · ORAL
SOTALOL HYDROCHLORIDEPrescription
SOTALOL HYDROCHLORIDE 160MG · TABLET · ORAL
SOTALOL HYDROCHLORIDEPrescription
SOTALOL HYDROCHLORIDE 80MG · TABLET · ORAL
Approval history
2023-09-11Labeling · Supplement 12 · standardAP
2023-09-11Labeling · Supplement 15 · standardAP
2021-01-27Labeling · Supplement 6 · standardAP
2002-09-26OriginalAP
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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