FDA NDA · NDA205108

SOTYLIZE

sotalol hydrochloride

Sponsor: AZURITY

APPLICATION

NDA205108

TYPE

NDA

ORIGINAL APPROVAL

2014-10-22

LATEST ACTION

2024-01-12

ROUTE

ORAL

DOSAGE FORM

SOLUTION

MARKETING STATUS

Prescription

Products

SOTYLIZE · ReferencePrescription

SOTALOL HYDROCHLORIDE 5MG/ML (5MG/ML) · SOLUTION · ORAL

2024-01-12Labeling · Supplement 3 · standard — Letter ↗AP

2015-06-16Manufacturing (CMC) · Supplement 1 · standardAP

2014-10-22Type 3 - New Dosage Form · Original · standard — Label ↗AP

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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