APPLICATION
ANDA075429
TYPE
ANDA
ORIGINAL APPROVAL
2000-05-01
LATEST ACTION
2024-05-15
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 240MG · TABLET · ORAL
SOTALOL HYDROCHLORIDEPrescription
SOTALOL HYDROCHLORIDE 120MG · TABLET · ORAL
Approval history
2024-05-15Labeling · Supplement 30 · standardAP
2022-10-25Labeling · Supplement 26 · standardAP
2021-02-04Labeling · Supplement 18 · standardAP
2014-10-24Manufacturing (CMC) · Supplement 16 · unknownAP
2014-09-04Labeling · Supplement 14AP
2012-01-11Labeling · Supplement 12AP
2011-04-28Labeling · Supplement 13AP
2006-12-26Labeling · Supplement 11AP
2002-12-03Labeling · Supplement 2AP
2000-10-13Labeling · Supplement 1AP
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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