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PROPAFENONE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ANI PHARMS · Approved 2004-04-23

Drug application

FDA Application #

ANDA076550

Application type

Abbreviated New Drug Application (Generic)

Brand name

PROPAFENONE HYDROCHLORIDE

Generic name

PROPAFENONE HYDROCHLORIDE

Active ingredients

PROPAFENONE HYDROCHLORIDE

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

ANI PHARMS

Manufacturer

ANI Pharmaceuticals, Inc.

First approval

2004-04-23

Source

Authoritative

Drugs@FDA application overview

Machine

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