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BONJESTA

NDA · New Drug Application · Sponsor: DUCHESNAY · Approved 2016-11-07

Drug application

FDA Application #

NDA209661

Application type

New Drug Application

Brand name

BONJESTA

Generic name

DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE

Active ingredients

DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

Marketing status

Prescription

Sponsor

DUCHESNAY

Manufacturer

Duchesnay USA, Inc.

First approval

2016-11-07

Source

Authoritative

Drugs@FDA application overview

Machine

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