Sotalol Hydrochloride 150mg/10ml NDA 022306
Summary
Altathera Pharmaceuticals LLC received FDA approval for Sotalol Hydrochloride (150mg/10ml, 15mg/ml) solution for intravenous administration under NDA 022306, approved July 2, 2009. The product is listed as both a Reference Listed Drug and Reference Standard with Prescription marketing status. Patent and exclusivity information is available through the linked Orange Book patent info page.
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GovPing monitors FDA Orange Book — New Patent Listings for new healthcare & life sciences regulatory changes. Every update since tracking began is archived, classified, and available as free RSS or email alerts — 3 changes logged to date.
What changed
The FDA Orange Book now includes a listing for Sotalol Hydrochloride 150mg/10ml (15mg/ml) solution for intravenous use, approved under NDA 022306 to Altathera Pharmaceuticals LLC. The product holds Reference Listed Drug and Reference Standard designations, indicating it may serve as a basis for Abbreviated New Drug Applications (ANDAs) seeking approval of generic versions. Affected parties seeking to reference this product in generic applications should consult the linked patent and exclusivity information page to determine any blocking patents or exclusivity periods.
Archived snapshot
Apr 23, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
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Product Details for NDA 022306
SOTALOL HYDROCHLORIDE (SOTALOL HYDROCHLORIDE)
150MG/10ML (15MG/ML)
Marketing Status:
Prescription Active Ingredient: SOTALOL HYDROCHLORIDE
Proprietary Name: SOTALOL HYDROCHLORIDE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 150MG/10ML (15MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N022306
Product Number: 001
Approval Date: Jul 2, 2009
Applicant Holder Full Name: ALTATHERA PHARMACEUTICALS LLC
Marketing Status: Prescription
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