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FDA NDA · NDA022306

SOTALOL HYDROCHLORIDE

Sponsor: ALTATHERA PHARMS LLC

APPLICATION
NDA022306
TYPE
NDA
ORIGINAL APPROVAL
2009-07-02
LATEST ACTION
2025-07-23
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

SOTALOL HYDROCHLORIDE · ReferencePrescription
SOTALOL HYDROCHLORIDE 150MG/10ML (15MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2025-07-23Efficacy · Supplement 8 · standard — Letter ↗AP
2023-09-21Labeling · Supplement 6 · standard — Letter ↗AP
2020-03-06Efficacy · Supplement 5 · standard — Label ↗AP
2015-09-25Manufacturing (CMC) · Supplement 4AP
2013-06-06Manufacturing (CMC) · Supplement 3AP
2009-07-02Type 3 - New Dosage Form · Original · standard — Label ↗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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