APPLICATION
ANDA207428
TYPE
ANDA
ORIGINAL APPROVAL
2016-10-21
LATEST ACTION
2026-06-30
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
SOTALOL HYDROCHLORIDEPrescription
SOTALOL HYDROCHLORIDE 160MG · TABLET · ORAL
SOTALOL HYDROCHLORIDEPrescription
SOTALOL HYDROCHLORIDE 80MG · TABLET · ORAL
SOTALOL HYDROCHLORIDEPrescription
SOTALOL HYDROCHLORIDE 120MG · TABLET · ORAL
Approval history
2026-06-30Labeling · Supplement 10 · standardAP
2016-10-21UNKNOWN · Original · 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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