FDA — authorised 24 December 1996
- Application: ANDA084300
- Marketing authorisation holder: ALCON LABS INC
- Indication: Labeling
- Status: approved
🇺🇸 Sudafed PE in United States
FDA authorised Sudafed PE on 24 December 1996
Marketing authorisations
FDA — authorised 20 December 2012
- Application: NDA203826
- Marketing authorisation holder: HIKMA
- Indication: Type 7 - Drug Already Marketed without Approved NDA
- Status: approved
FDA — authorised 15 January 2016
- Application: NDA205388
- Marketing authorisation holder: RAYNER SURGICAL
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 11 June 2020
- Application: ANDA213318
- Marketing authorisation holder: CAPLIN
- Status: approved
FDA — authorised 30 August 2022
- Application: ANDA217069
- Marketing authorisation holder: MANKIND PHARMA
- Status: approved
Sudafed PE 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 PE approved in United States?
Yes. FDA authorised it on 24 December 1996; FDA authorised it on 20 December 2012; FDA authorised it on 15 January 2016.
Who is the marketing authorisation holder for Sudafed PE in United States?
ALCON LABS INC holds the US marketing authorisation.