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MEXILETINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ANI PHARMS · Approved 1996-05-16

Drug application

FDA Application #

ANDA074450

Application type

Abbreviated New Drug Application (Generic)

Brand name

MEXILETINE HYDROCHLORIDE

Generic name

MEXILETINE HYDROCHLORIDE

Active ingredients

MEXILETINE HYDROCHLORIDE

Dosage form

CAPSULE

Route

ORAL

Marketing status

Prescription

Sponsor

ANI PHARMS

Manufacturer

ANI Pharmaceuticals, Inc.

First approval

1996-05-16

Source

Authoritative

Drugs@FDA application overview

Machine

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