APPLICATION
ANDA075237
TYPE
ANDA
ORIGINAL APPROVAL
2000-05-01
LATEST ACTION
2015-09-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
SOTALOL HYDROCHLORIDEDiscontinued
SOTALOL HYDROCHLORIDE 160MG · TABLET · ORAL
SOTALOL HYDROCHLORIDEDiscontinued
SOTALOL HYDROCHLORIDE 80MG · TABLET · ORAL
SOTALOL HYDROCHLORIDEDiscontinued
SOTALOL HYDROCHLORIDE 240MG · TABLET · ORAL
SOTALOL HYDROCHLORIDEDiscontinued
SOTALOL HYDROCHLORIDE 120MG · TABLET · ORAL
Approval history
2015-09-01Labeling · Supplement 8 · standardAP
2015-09-01Labeling · Supplement 6AP
2002-10-31Labeling · Supplement 3AP
2002-06-24Manufacturing (CMC) · 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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