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FDA ANDA · ANDA207429

SOTALOL HYDROCHLORIDE AF

sotalol hydrochloride tables af

Sponsor: REGCON HOLDINGS

APPLICATION
ANDA207429
TYPE
ANDA
ORIGINAL APPROVAL
2018-11-02
LATEST ACTION
2026-06-05
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 120MG · TABLET · ORAL

Approval history

2026-06-05Labeling · Supplement 8 · standardAP
2018-11-02UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

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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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