FDA — authorised 9 July 2004
- Application: NDA021441
- Marketing authorisation holder: HALEON US HOLDINGS
- Indication: Labeling
- Status: approved
🇺🇸 CHLORPHENIRAMINE in United States
FDA authorised CHLORPHENIRAMINE on 9 July 2004
Marketing authorisations
FDA — authorised 13 May 2009
- Application: ANDA040829
- Marketing authorisation holder: AVANTHI INC
- Status: approved
FDA — authorised 25 August 2016
- Application: NDA206323
- Marketing authorisation holder: MAINPOINTE
- Indication: Labeling
- Status: approved
FDA — authorised 27 December 2017
- Application: ANDA091632
- Marketing authorisation holder: TRIS PHARMA INC
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 9 July 2019
- Application: NDA022113
- Marketing authorisation holder: HALEON US HOLDINGS
- Indication: Labeling
- Status: approved
CHLORPHENIRAMINE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Respiratory approved in United States
Frequently asked questions
Is CHLORPHENIRAMINE approved in United States?
Yes. FDA authorised it on 9 July 2004; FDA authorised it on 13 May 2009; FDA authorised it on 25 August 2016.
Who is the marketing authorisation holder for CHLORPHENIRAMINE in United States?
HALEON US HOLDINGS holds the US marketing authorisation.