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PROPAFENONE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: UPSHER SMITH LABS · Approved 2020-06-25

Drug application

FDA Application #

ANDA212744

Application type

Abbreviated New Drug Application (Generic)

Brand name

PROPAFENONE HYDROCHLORIDE

Generic name

PROPAFENONE HYDROCHLORIDE

Active ingredients

PROPAFENONE HYDROCHLORIDE

Dosage form

CAPSULE, EXTENDED RELEASE

Route

ORAL

Marketing status

Prescription

Sponsor

UPSHER SMITH LABS

Manufacturer

Upsher-Smith Laboratories, LLC

First approval

2020-06-25

Source

Authoritative

Drugs@FDA application overview

Machine

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