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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
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Farmers Insurance
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Fish and Richardson
Cerilliant
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Generated: February 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078540

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NDA 078540 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 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 078540
Tradename:PROPAFENONE HYDROCHLORIDE
Applicant:Par Pharm
Ingredient:propafenone hydrochloride
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 078540
Medical Subject Heading (MeSH) Categories for 078540
Suppliers and Packaging for NDA: 078540
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROPAFENONE HYDROCHLORIDE propafenone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 078540 ANDA Rebel Distributors Corp 21695-814 E 21695-814-60
PROPAFENONE HYDROCHLORIDE propafenone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 078540 ANDA AvKARE, Inc. 42291-545 N 42291-545-60

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength225MG
Approval Date:Oct 18, 2010TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength325MG
Approval Date:Oct 18, 2010TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength425MG
Approval Date:Oct 18, 2010TE:ABRLD:No

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US Army
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Harvard Business School
Dow
Queensland Health

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