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Generated: December 11, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203803

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NDA 203803 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 eighteen 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. Twenty suppliers are listed for this compound. Additional details are available on the propafenone hydrochloride profile page.

Summary for 203803

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 203803

Medical Subject Heading (MeSH) Categories for 203803

Suppliers and Packaging for NDA: 203803

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROPAFENONE HYDROCHLORIDE propafenone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 203803 ANDA Mylan Pharmaceuticals Inc. 0378-1258 0378-1258-91 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-1258-91)
PROPAFENONE HYDROCHLORIDE propafenone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 203803 ANDA Mylan Pharmaceuticals Inc. 0378-1258 0378-1258-05 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-1258-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength225MG
Approval Date:Apr 29, 2016TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength325MG
Approval Date:Apr 29, 2016TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength425MG
Approval Date:Apr 29, 2016TE:ABRLD:No


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