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

Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
QuintilesIMS
Argus Health
Cerilliant
Chinese Patent Office
Cantor Fitzgerald
Johnson and Johnson
Harvard Business School
Mallinckrodt

Generated: June 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075938

« Back to Dashboard

NDA 075938 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 075938
Tradename:PROPAFENONE HYDROCHLORIDE
Applicant:Vintage Pharms
Ingredient:propafenone hydrochloride
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 075938
Medical Subject Heading (MeSH) Categories for 075938
Suppliers and Packaging for NDA: 075938
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROPAFENONE HYDROCHLORIDE propafenone hydrochloride TABLET;ORAL 075938 ANDA Par Pharmaceutical 0603-5448 N 0603-5448-21
PROPAFENONE HYDROCHLORIDE propafenone hydrochloride TABLET;ORAL 075938 ANDA Par Pharmaceutical 0603-5448 N 0603-5448-25

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Oct 17, 2002TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength225MG
Approval Date:Oct 17, 2002TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:Oct 17, 2002TE:ABRLD: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
Dow
UBS
Johnson and Johnson
Citi
Mallinckrodt
Covington
Federal Trade Commission
Chinese Patent Office

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.