Hycofenix

NDA 22279, held by Chartwell Rx. Guaifenesin; Hydrocodone Bitartrate; Pseudoephedrine Hydrochloride.

As of Nov 13, 2026, NDA 22279 (Hycofenix), held by Chartwell Rx, was first approved by FDA on May 14, 2015, with 4 approved supplements and 0 published complete response letters.

First approved: May 14, 2015
Review: Standard
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
May 14, 2015	Original applicationNew combination · Standard review	Approved	Summary Review Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Hycofenix200MG/5ML;2.5MG/5ML;30MG/5ML · solution;oral	Guaifenesin; Hydrocodone Bitartrate; Pseudoephedrine Hydrochloride	DiscontinuedReference drug

All 5 submissions, including labeling and manufacturing supplements


Dec 22, 2025	Supplement 4Labeling · Standard review	Approved	Medication Guide Letter Label
Dec 15, 2023	Supplement 3Labeling · Standard review	Approved	Letter Label
Jun 28, 2018	Supplement 2Labeling · Standard review	Approved	Letter Label
Jan 13, 2017	Supplement 1Labeling · Standard review	Approved	Letter Label
May 14, 2015	Original applicationNew combination · Standard review	Approved	Summary Review Review Letter Label

Identifiers

Application: NDA 22279
Drugs@FDA: Overview at FDA
Company: Chartwell RX

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters