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Last Updated: January 27, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075515

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NDA 075515 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 twelve suppliers. 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. Sixteen suppliers are listed for this compound. Additional details are available on the sotalol hydrochloride profile page.
Summary for 075515
Tradename:SOTALOL HYDROCHLORIDE
Applicant:Sun Pharm Industries
Ingredient:sotalol hydrochloride
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 075515

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength80MG
Approval Date:Oct 15, 2001TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength160MG
Approval Date:Oct 15, 2001TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength240MG
Approval Date:Oct 15, 2001TE:RLD:No

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Serving leading biopharmaceutical companies globally:

Medtronic
Dow
McKinsey
Colorcon
Johnson and Johnson
McKesson

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