← FDA DRUG APPROVALS

FDA ANDA · ANDA075515

SOTALOL HYDROCHLORIDE

Sponsor: SUN PHARM INDUSTRIES

APPLICATION
ANDA075515
TYPE
ANDA
ORIGINAL APPROVAL
2001-10-15
LATEST ACTION
2004-08-06
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

SOTALOL HYDROCHLORIDEDiscontinued
SOTALOL HYDROCHLORIDE 120MG · TABLET · ORAL
SOTALOL HYDROCHLORIDEDiscontinued
SOTALOL HYDROCHLORIDE 160MG · TABLET · ORAL
SOTALOL HYDROCHLORIDEDiscontinued
SOTALOL HYDROCHLORIDE 240MG · TABLET · ORAL
SOTALOL HYDROCHLORIDEDiscontinued
SOTALOL HYDROCHLORIDE 80MG · TABLET · ORAL

Approval history

2004-08-06Labeling · Supplement 5AP
2003-04-07Labeling · Supplement 3AP
2001-10-15Original — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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