Zutripro

NDA 22439, held by Persion. Chlorpheniramine Maleate; Hydrocodone Bitartrate; Pseudoephedrine Hydrochloride.

As of Nov 14, 2026, NDA 22439 (Zutripro), held by Persion, was first approved by FDA on Jun 8, 2011, with 3 approved supplements and 0 published complete response letters.

First approved: Jun 8, 2011
Review: Standard
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Jun 8, 2011	Original applicationNew combination · Standard review	Approved	Review Summary Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Zutripro4MG/5ML;5MG/5ML;60MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · solution;oral	Chlorpheniramine Maleate; Hydrocodone Bitartrate; Pseudoephedrine Hydrochloride	DiscontinuedReference drug

All 4 submissions, including labeling and manufacturing supplements


Jun 28, 2018	Supplement 10Labeling · Standard review	Approved	Medication Guide Letter Label
Jan 13, 2017	Supplement 9Labeling · Standard review	Approved	Letter Label
Sep 26, 2014	Supplement 7Manufacturing · Standard review	Approved	None posted
Jun 8, 2011	Original applicationNew combination · Standard review	Approved	Review Summary Review Letter Label

Identifiers

Application: NDA 22439
Drugs@FDA: Overview at FDA
Company: Persion

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