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Last Updated: December 15, 2025

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, Aurobindo Pharma Usa, Epic Pharma Llc, Impax Pharms, Novitium Pharma, Oxford Pharms, Regcon Holdings, Rising, Sun Pharm Industries, Teva, Upsher Smith Labs, and Watson Labs, and is included in seventeen NDAs. It is available from eighteen suppliers. There are six 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. Twenty-one 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

Medical Subject Heading (MeSH) Categories for 075515

Adrenergic beta-Antagonists
Anti-Arrhythmia Agents
Sympatholytics

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	80MG
Approval Date:	Oct 15, 2001	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	160MG
Approval Date:	Oct 15, 2001	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	240MG
Approval Date:	Oct 15, 2001	TE:		RLD:	No

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