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Last Updated: October 21, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207428


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NDA 207428 describes SOTALOL HYDROCHLORIDE, which is a drug marketed by Altathera Pharms Llc, Apotex, Beximco Pharms Usa, Epic Pharma Inc, Impax Pharms, Mylan, Oxford Pharms, Sun Pharm Industries, Teva, Upsher Smith Labs, and Watson Labs, and is included in seventeen NDAs. It is available from fourteen suppliers. There are two patents protecting this drug. Additional details are available on the SOTALOL HYDROCHLORIDE profile page.

The generic ingredient in SOTALOL HYDROCHLORIDE is sotalol hydrochloride. There are ten drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the sotalol hydrochloride profile page.
Summary for 207428
Tradename:SOTALOL HYDROCHLORIDE
Applicant:Beximco Pharms Usa
Ingredient:sotalol hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 207428
Mechanism of ActionAdrenergic beta-Antagonists
Physiological EffectCardiac Rhythm Alteration
Medical Subject Heading (MeSH) Categories for 207428
Suppliers and Packaging for NDA: 207428
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SOTALOL HYDROCHLORIDE sotalol hydrochloride TABLET;ORAL 207428 ANDA Marlex Pharmaceuticals Inc 10135-661 10135-661-01 100 TABLET in 1 BOTTLE, PLASTIC (10135-661-01)
SOTALOL HYDROCHLORIDE sotalol hydrochloride TABLET;ORAL 207428 ANDA Marlex Pharmaceuticals Inc 10135-661 10135-661-50 500 TABLET in 1 BOTTLE, PLASTIC (10135-661-50)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength80MG
Approval Date:Oct 21, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength120MG
Approval Date:Oct 21, 2016TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength160MG
Approval Date:Oct 21, 2016TE:ABRLD:No

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