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Sotalol hydrochlorideis the generic ingredient in five branded drugs marketed by Altathera Pharms Llc, Arbor Pharms Llc, Covis Pharma Bv, Upsher Smith Labs, Apotex, 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 three 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 ten drug master file entries for sotalol hydrochloride. Sixteen suppliers are listed for this compound.
Summary for sotalol hydrochloride
Recent Clinical Trials for sotalol hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
|Vanderbilt University Medical Center||Phase 3|
|Shengjing Hospital||Phase 4|
|Wojciech Zareba||Phase 2|
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|
|Covis Pharma Bv||BETAPACE AF||sotalol hydrochloride||TABLET;ORAL||021151-002||Feb 22, 2000||AB||RX||Yes||No||Start Trial||Start Trial||Start Trial|
|Teva||SOTALOL HYDROCHLORIDE||sotalol hydrochloride||TABLET;ORAL||075429-001||May 1, 2000||AB||RX||No||No||Start Trial||Start Trial||Start Trial|
|Impax Pharms||SOTALOL HYDROCHLORIDE||sotalol hydrochloride||TABLET;ORAL||075663-002||Nov 7, 2000||DISCN||No||No||Start Trial||Start Trial||Start Trial|
|Apotex||SOTALOL HYDROCHLORIDE||sotalol hydrochloride||TABLET;ORAL||076140-003||Sep 26, 2002||AB||RX||No||No||Start Trial||Start Trial||Start Trial|
|Sun Pharm Industries||SOTALOL HYDROCHLORIDE||sotalol hydrochloride||TABLET;ORAL||076576-003||Apr 8, 2004||DISCN||No||No||Start Trial||Start Trial||Start Trial|
|Apotex||SOTALOL HYDROCHLORIDE||sotalol hydrochloride||TABLET;ORAL||076140-002||Sep 26, 2002||AB||RX||No||No||Start Trial||Start Trial||Start Trial|
|>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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