Last Updated: November 8, 2026

Details for New Drug Application (NDA): 212744

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NDA 212744 describes PROPAFENONE HYDROCHLORIDE, which is a drug marketed by Aurobindo Pharma Ltd, Glenmark Pharms Ltd, Mylan, Rising, Sinotherapeutics Inc, Strides Pharma Intl, Twi Pharms, Upsher Smith Labs, Watson Labs Inc, Zydus Lifesciences, Ani Pharms, Aurobindo Pharma, Nesher Pharms, Sun Pharm Industries, and Watson Labs, and is included in sixteen NDAs. It is available from fourteen suppliers. Additional details are available on the PROPAFENONE HYDROCHLORIDE profile page.

The generic ingredient in PROPAFENONE HYDROCHLORIDE is propafenone hydrochloride. There is one drug master file entry for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the propafenone hydrochloride profile page.
Summary for 212744
Tradename:PROPAFENONE HYDROCHLORIDE
Applicant:Upsher Smith Labs
Ingredient:propafenone hydrochloride
Patents:0
Pharmacology for NDA: 212744
Medical Subject Heading (MeSH) Categories for 212744
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Suppliers and Packaging for NDA: 212744
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROPAFENONE HYDROCHLORIDE propafenone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 212744 ANDA Upsher-Smith Laboratories, LLC 0832-0742 0832-0742-60 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0832-0742-60)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength225MG
Approval Date:Jun 25, 2020TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength325MG
Approval Date:Jun 25, 2020TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength425MG
Approval Date:Jun 25, 2020TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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