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Covington
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Generated: May 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076550

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NDA 076550 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 076550
Tradename:PROPAFENONE HYDROCHLORIDE
Applicant:Ani Pharms Inc
Ingredient:propafenone hydrochloride
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 076550
Medical Subject Heading (MeSH) Categories for 076550
Suppliers and Packaging for NDA: 076550
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROPAFENONE HYDROCHLORIDE propafenone hydrochloride TABLET;ORAL 076550 ANDA ANI Pharmaceuticals, Inc. 62559-230 N 62559-230-01
PROPAFENONE HYDROCHLORIDE propafenone hydrochloride TABLET;ORAL 076550 ANDA ANI Pharmaceuticals, Inc. 62559-231 N 62559-231-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Apr 23, 2004TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength225MG
Approval Date:Apr 23, 2004TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:Apr 23, 2004TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
Merck
Boehringer Ingelheim
Daiichi Sankyo
Cerilliant
Mallinckrodt
Johnson and Johnson
Julphar
Cipla

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