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LOFEXIDINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: NOVITIUM PHARMA · Approved 2025-10-22

Drug application

FDA Application #

ANDA219917

Application type

Abbreviated New Drug Application (Generic)

Brand name

LOFEXIDINE HYDROCHLORIDE

Generic name

LOFEXIDINE

Active ingredients

LOFEXIDINE HYDROCHLORIDE

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

NOVITIUM PHARMA

Manufacturer

ANI Pharmaceuticals, Inc.

First approval

2025-10-22

Source

Authoritative

Drugs@FDA application overview

Machine

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