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Serving 500+ biopharmaceutical companies globally:

Fuji
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Cipla
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Express Scripts
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Farmers Insurance
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Generated: August 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202688

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NDA 202688 describes PROPAFENONE HYDROCHLORIDE, which is a drug marketed by Mylan Pharms Inc, Watson Labs, Vintage Pharms, Par Pharm, Orion Corp Orion, Ani Pharms Inc, Watson Labs Inc, Nesher Pharms, and Sun Pharm Inds, and is included in nine 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 NDA: 202688

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

Pharmacology for NDA: 202688

Suppliers and Packaging for NDA: 202688

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROPAFENONE HYDROCHLORIDE
propafenone hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL 202688 ANDA Actavis Pharma, Inc. 0591-2285 0591-2285-60 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0591-2285-60)
PROPAFENONE HYDROCHLORIDE
propafenone hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL 202688 ANDA Actavis Pharma, Inc. 0591-2286 0591-2286-60 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0591-2286-60)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength225MG
Approval Date:Aug 24, 2015TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength325MG
Approval Date:Aug 24, 2015TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength425MG
Approval Date:Aug 24, 2015TE:ABRLD:No


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Daiichi Sankyo
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