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Sotalol hydrochlorideis the generic ingredient in five branded drugs marketed by Altathera Pharms Llc, Azurity, Covis, Upsher Smith Labs, Apotex, Aurobindo Pharma Usa, Beximco Pharms Usa, Epic Pharma Inc, Impax Pharms, Mylan, Oxford Pharms, Sun Pharm Industries, Teva, and Watson Labs, and is included in twenty-one NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.
Sotalol hydrochloride has one patent family member in one country.
There are seven drug master file entries for sotalol hydrochloride. Twenty suppliers are listed for this compound.
Summary for sotalol hydrochloride
|Drug Master File Entries:||7|
|Finished Product Suppliers / Packagers:||20|
|Raw Ingredient (Bulk) Api Vendors:||102|
|Formulation / Manufacturing:||see details|
|Patent Litigation and PTAB cases:||See patent lawsuits and PTAB cases for sotalol hydrochloride|
|What excipients (inactive ingredients) are in sotalol hydrochloride?||sotalol hydrochloride excipients list|
|DailyMed Link:||sotalol hydrochloride at DailyMed|
Recent Clinical Trials for sotalol hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
|Abant Izzet Baysal University||N/A|
|Duke Clinical Research Institute||Phase 4|
Pharmacology for sotalol hydrochloride
|Drug Class|| Antiarrhythmic |
|Mechanism of Action||Adrenergic beta-Antagonists |
|Physiological Effect|| Cardiac Rhythm Alteration |
Medical Subject Heading (MeSH) Categories for sotalol hydrochloride
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||TE||Type||RLD||RS||Patent No.||Patent Expiration||Product||Substance||Delist Req.||Exclusivity Expiration|
|Oxford Pharms||SOTALOL HYDROCHLORIDE||sotalol hydrochloride||TABLET;ORAL||075563-001||Nov 7, 2003||AB||RX||No||No||See Plans and Pricing||See Plans and Pricing||See Plans and Pricing|
|Apotex||SOTALOL HYDROCHLORIDE||sotalol hydrochloride||TABLET;ORAL||076214-002||Aug 27, 2003||AB||RX||No||No||See Plans and Pricing||See Plans and Pricing||See Plans and Pricing|
|Beximco Pharms Usa||SOTALOL HYDROCHLORIDE||sotalol hydrochloride||TABLET;ORAL||207428-002||Oct 21, 2016||AB||RX||No||No||See Plans and Pricing||See Plans and Pricing||See Plans and Pricing|
|>Applicant||>Tradename||>Generic Name||>Dosage||>NDA||>Approval Date||>TE||>Type||>RLD||>RS||>Patent No.||>Patent Expiration||>Product||>Substance||>Delist Req.||>Exclusivity Expiration|
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