FDA — authorised 26 November 2004
- Application: ANDA075706
- Marketing authorisation holder: P AND L
- Indication: Labeling
- Status: approved
🇺🇸 Sudafed in United States
FDA authorised Sudafed on 26 November 2004
Marketing authorisations
FDA — authorised 27 March 2009
- Application: ANDA075989
- Marketing authorisation holder: PERRIGO PHARMA INTL
- Indication: Labeling
- Status: approved
FDA — authorised 20 December 2010
- Application: NDA021585
- Marketing authorisation holder: RB HLTH
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 16 June 2020
- Application: ANDA211170
- Marketing authorisation holder: HIBROW HLTHCARE
- Status: approved
FDA — authorised 20 May 2025
- Application: ANDA090922
- Marketing authorisation holder: SUN PHARM INDS LTD
- Indication: Labeling
- Status: approved
The FDA granted marketing authorisation to SUN PHARM INDS LTD for Sudafed on 2025-05-20. The approval was based on a standard expedited pathway application (ANDA090922). The approved indication for Sudafed is its labeling, which has not been specified in the provided information.
Sudafed 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 Sudafed approved in United States?
Yes. FDA authorised it on 26 November 2004; FDA authorised it on 27 March 2009; FDA authorised it on 20 December 2010.
Who is the marketing authorisation holder for Sudafed in United States?
P AND L holds the US marketing authorisation.