APPLICATION
ANDA075500
TYPE
ANDA
ORIGINAL APPROVAL
2001-04-27
LATEST ACTION
2021-02-04
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
SORINEPrescription
SOTALOL HYDROCHLORIDE 80MG · TABLET · ORAL
SORINEPrescription
SOTALOL HYDROCHLORIDE 120MG · TABLET · ORAL
SORINEPrescription
SOTALOL HYDROCHLORIDE 160MG · TABLET · ORAL
SORINEPrescription
SOTALOL HYDROCHLORIDE 240MG · TABLET · ORAL
Approval history
2021-02-04Labeling · Supplement 17 · standardAP
2015-03-02Labeling · Supplement 14AP
2015-03-02Labeling · Supplement 15AP
2003-05-13Labeling · Supplement 2AP
2002-12-19Manufacturing (CMC) · 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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