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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 210339


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NDA 210339 describes PROPAFENONE HYDROCHLORIDE, which is a drug marketed by Aurobindo Pharma Ltd, Glenmark Pharms Ltd, Mylan, Rising, Sinotherapeutics Inc, Strides Pharma, 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 nineteen suppliers. Additional details are available on the PROPAFENONE HYDROCHLORIDE profile page.

The generic ingredient in PROPAFENONE HYDROCHLORIDE is propafenone hydrochloride. There are eleven drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the propafenone hydrochloride profile page.
Summary for 210339
Pharmacology for NDA: 210339
Medical Subject Heading (MeSH) Categories for 210339
Suppliers and Packaging for NDA: 210339
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROPAFENONE HYDROCHLORIDE propafenone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 210339 ANDA Vitruvias Therapeutics 69680-130 69680-130-60 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (69680-130-60)
PROPAFENONE HYDROCHLORIDE propafenone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 210339 ANDA Vitruvias Therapeutics 69680-130 69680-130-92 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (69680-130-92)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength225MG
Approval Date:Jan 4, 2019TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength325MG
Approval Date:Jan 4, 2019TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength425MG
Approval Date:Jan 4, 2019TE:ABRLD:No

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