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Serving leading biopharmaceutical companies globally:

Harvard Business School
Boehringer Ingelheim
Fish and Richardson
Farmers Insurance

Generated: January 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075203

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NDA 075203 describes PROPAFENONE HYDROCHLORIDE, which is a drug marketed by Glenmark Pharms Ltd, Mylan Pharms Inc, Par Pharm, Watson Labs Inc, Ani Pharms Inc, Nesher Pharms, Orion Corp Orion, Sun Pharm Industries, Vintage Pharms, and Watson Labs, and is included in ten NDAs. It is available from seventeen 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. Nineteen suppliers are listed for this compound. Additional details are available on the propafenone hydrochloride profile page.
Summary for 075203
Applicant:Watson Labs
Ingredient:propafenone hydrochloride
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 075203
Medical Subject Heading (MeSH) Categories for 075203
Suppliers and Packaging for NDA: 075203
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROPAFENONE HYDROCHLORIDE propafenone hydrochloride TABLET;ORAL 075203 ANDA Actavis Pharma, Inc. 0591-0582 0591-0582-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-0582-01)
PROPAFENONE HYDROCHLORIDE propafenone hydrochloride TABLET;ORAL 075203 ANDA Actavis Pharma, Inc. 0591-0583 0591-0583-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-0583-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Oct 24, 2000TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength225MG
Approval Date:Oct 24, 2000TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Boehringer Ingelheim
Harvard Business School
Chinese Patent Office
Argus Health
Federal Trade Commission
Farmers Insurance

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