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McKesson
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Fish and Richardson
Dow
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Generated: April 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075938

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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 thirteen 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. Fifteen 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 0603-5448-25
PROPAFENONE HYDROCHLORIDE propafenone hydrochloride TABLET;ORAL 075938 ANDA Par Pharmaceutical 0603-5448 N 0603-5448-21

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

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Serving hundreds of leading biopharmaceutical companies globally:

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Harvard Business School
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Colorcon
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