Xtrelus

NDA 208085, held by Eci Pharms LLC. Guaifenesin; Hydrocodone Bitartrate.

As of Nov 13, 2026, NDA 208085 (Xtrelus), held by Eci Pharms LLC, was first approved by FDA on Apr 25, 2018, with 3 approved supplements and 0 published complete response letters.

First approved: Apr 25, 2018
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
Apr 25, 2018	Original applicationTYPE 3/4 · Standard review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Xtrelus400MG;5MG · tablet;oral	Guaifenesin; Hydrocodone Bitartrate	DiscontinuedReference drug

All 4 submissions, including labeling and manufacturing supplements


Dec 22, 2025	Supplement 3Labeling · Standard review	Approved	Label Letter
Dec 15, 2023	Supplement 2Labeling · Standard review	Approved	Letter Label Medication Guide
Oct 31, 2018	Supplement 1Labeling · Standard review	Approved	Letter Label
Apr 25, 2018	Original applicationTYPE 3/4 · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 208085
Drugs@FDA: Overview at FDA
Company: ECI Pharmaceuticals

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