APPLICATION
ANDA077616
TYPE
ANDA
ORIGINAL APPROVAL
2007-02-07
LATEST ACTION
2024-04-30
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
2024-04-30Labeling · Supplement 5 · standardAP
2024-04-30Labeling · Supplement 8 · standardAP
2015-08-25Labeling · Supplement 4AP
2007-02-07OriginalAP
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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