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Details for New Drug Application (NDA): 203803

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NDA 203803 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 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 NDA: 203803

Tradename:
PROPAFENONE HYDROCHLORIDE
Applicant:
Mylan Pharms Inc
Ingredient:
propafenone hydrochloride
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 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 0378-1258-05 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-1258-05)
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)

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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