Obredon

NDA 205474, held by Sovereign Pharms. Guaifenesin; Hydrocodone Bitartrate.

As of Nov 15, 2026, NDA 205474 (Obredon), held by Sovereign Pharms, was first approved by FDA on Nov 14, 2014, with 5 approved supplements and 0 published complete response letters.

First approved: Nov 14, 2014
Review: Standard
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Nov 14, 2014	Original applicationNew combination · Standard review	Approved	Review Summary Review Label Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Obredon200MG/5ML;2.5MG/5ML · solution;oral	Guaifenesin; Hydrocodone Bitartrate	DiscontinuedReference drug

All 6 submissions, including labeling and manufacturing supplements


Dec 22, 2025	Supplement 9Labeling · Standard review	Approved	Label Letter
Dec 15, 2023	Supplement 8Labeling · Standard review	Approved	Letter Label Medication Guide
Jun 28, 2018	Supplement 5Labeling · Standard review	Approved	Letter Label
Jan 13, 2017	Supplement 3Labeling · Standard review	Approved	Letter Label
Jun 19, 2015	Supplement 1Manufacturing · Standard review	Approved	None posted
Nov 14, 2014	Original applicationNew combination · Standard review	Approved	Review Summary Review Label Letter

Identifiers

Application: NDA 205474
Drugs@FDA: Overview at FDA
Company: Sovereign 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