APPLICATION
ANDA075563
TYPE
ANDA
ORIGINAL APPROVAL
2003-11-07
LATEST ACTION
2023-09-12
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
2023-09-12Labeling · Supplement 24 · standardAP
2023-02-28Labeling · Supplement 22 · standardAP
2020-10-29Labeling · Supplement 18 · standardAP
2015-04-28Labeling · Supplement 7AP
2011-04-28Labeling · Supplement 6AP
2007-03-01Labeling · Supplement 3AP
2003-11-07OriginalAP
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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