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Serving hundreds of leading biopharmaceutical companies globally:

Generated: June 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203803

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NDA 203803 describes PROPAFENONE HYDROCHLORIDE, which is a drug marketed by Glenmark Pharms Ltd, Mylan Pharms Inc, Par Pharm, Watson Labs Inc, Ani Pharms Inc, Aurobindo Pharma Ltd, Nesher Pharms, Sun Pharm Industries, Vintage Pharms, and Watson Labs, and is included in ten NDAs. It is available from fifteen 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. Seventeen suppliers are listed for this compound. Additional details are available on the propafenone hydrochloride profile page.

Summary for 203803

Tradename:	PROPAFENONE HYDROCHLORIDE
Applicant:	Mylan Pharms Inc
Ingredient:	propafenone hydrochloride
Patents:	0
Therapeutic Class:	Cardiovascular Agents
Formulation / Manufacturing:	see details

Pharmacology for NDA: 203803

Medical Subject Heading (MeSH) Categories for 203803

Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers

Suppliers and Packaging for NDA: 203803

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PROPAFENONE HYDROCHLORIDE	propafenone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	203803	ANDA	Mylan Pharmaceuticals Inc.	0378-1258	N	0378-1258-91
PROPAFENONE HYDROCHLORIDE	propafenone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	203803	ANDA	Mylan Pharmaceuticals Inc.	0378-1259	N	0378-1259-91

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	225MG
Approval Date:	Apr 29, 2016	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	325MG
Approval Date:	Apr 29, 2016	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	425MG
Approval Date:	Apr 29, 2016	TE:	AB	RLD:	No

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