Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Generated: April 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075998

« Back to Dashboard

NDA 075998 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 sixteen 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. Eighteen suppliers are listed for this compound. Additional details are available on the propafenone hydrochloride profile page.

Summary for 075998

Tradename:	PROPAFENONE HYDROCHLORIDE
Applicant:	Sun Pharm Industries
Ingredient:	propafenone hydrochloride
Patents:	0
Therapeutic Class:	Cardiovascular Agents
Formulation / Manufacturing:	see details

Pharmacology for NDA: 075998

Medical Subject Heading (MeSH) Categories for 075998

Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers

Suppliers and Packaging for NDA: 075998

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PROPAFENONE HYDROCHLORIDE	propafenone hydrochloride	TABLET;ORAL	075998	ANDA	Mylan Institutional Inc.	51079-996	N	51079-996-20
PROPAFENONE HYDROCHLORIDE	propafenone hydrochloride	TABLET;ORAL	075998	ANDA	Sun Pharmaceutical Industries, Inc.	53489-551	N	53489-551-01

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	150MG
Approval Date:	Nov 29, 2001	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	225MG
Approval Date:	Nov 29, 2001	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	300MG
Approval Date:	Nov 29, 2001	TE:	AB	RLD:	No

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance

Johnson and Johnson

Healthtrust

Fuji

AstraZeneca

Federal Trade Commission

Accenture

McKinsey

Baxter

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.