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XTRELUS

NDA · New Drug Application · Sponsor: ECI PHARMS LLC · Approved 2018-04-25

Drug application

FDA Application #

NDA208085

Application type

New Drug Application

Brand name

XTRELUS

Generic name

Guaifenesin

Active ingredients

GUAIFENESIN; HYDROCODONE BITARTRATE

Dosage form

TABLET

Route

ORAL

Marketing status

Discontinued

Sponsor

ECI PHARMS LLC

First approval

2018-04-25

Source

Authoritative

Drugs@FDA application overview

Machine

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