FDA — authorised 18 December 2002
- Application: NDA021282
- Marketing authorisation holder: RB HLTH
- Indication: Manufacturing (CMC)
- Status: approved
🇺🇸 Mucinex in United States
FDA authorised Mucinex on 18 December 2002
Marketing authorisations
FDA — authorised 20 December 2010
- Application: NDA021585
- Marketing authorisation holder: RB HLTH
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 23 November 2011
- Application: ANDA078912
- Marketing authorisation holder: PERRIGO R AND D
- Local brand name: GUAIFENESIN
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 14 November 2014
- Application: NDA205474
- Marketing authorisation holder: SOVEREIGN PHARMS
- Local brand name: OBREDON
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 17 March 2017
- Application: ANDA206941
- Marketing authorisation holder: AUROBINDO PHARMA
- Status: approved
FDA — authorised 29 December 2017
- Application: ANDA208369
- Marketing authorisation holder: DR REDDYS
- Local brand name: GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 5 March 2018
- Application: ANDA207602
- Marketing authorisation holder: PERRIGO R AND D
- Status: approved
FDA — authorised 21 October 2019
- Application: ANDA210453
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: GUAIFENESIN
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 31 January 2020
- Application: NDA021620
- Marketing authorisation holder: RB HLTH
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 25 March 2020
- Application: ANDA213203
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 28 April 2020
- Application: ANDA212542
- Marketing authorisation holder: SUN PHARM INDS INC
- Local brand name: GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 1 February 2022
- Application: ANDA214407
- Marketing authorisation holder: L PERRIGO CO
- Local brand name: GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 22 August 2022
- Application: ANDA216082
- Marketing authorisation holder: GRANULES
- Local brand name: GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 21 August 2023
- Application: ANDA217780
- Marketing authorisation holder: MARKSANS PHARMA
- Local brand name: GUAIFENESIN
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
Mucinex in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Infectious Disease approved in United States
Frequently asked questions
Is Mucinex approved in United States?
Yes. FDA authorised it on 18 December 2002; FDA authorised it on 20 December 2010; FDA authorised it on 23 November 2011.
Who is the marketing authorisation holder for Mucinex in United States?
RB HLTH holds the US marketing authorisation.