FDA — authorised 14 July 1981
- Status: approved
🇺🇸 Dexchlorpheniramine Maleate in United States
FDA authorised Dexchlorpheniramine Maleate on 14 July 1981
Marketing authorisations
FDA — authorised 14 July 1981
- Application: ANDA086835
- Marketing authorisation holder: SCHERING
- Local brand name: POLARAMINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 July 1982
- Application: ANDA086837
- Marketing authorisation holder: SCHERING
- Local brand name: POLARAMINE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 23 March 1984
- Application: ANDA088251
- Marketing authorisation holder: PAI HOLDINGS PHARM
- Local brand name: DEXCHLORPHENIRAMINE MALEATE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 17 January 1986
- Application: ANDA088682
- Marketing authorisation holder: ANI PHARMS
- Local brand name: DEXCHLORPHENIRAMINE MALEATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 July 2018
- Application: ANDA202520
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: POLMON
- Indication: SYRUP — ORAL
- Status: approved
Dexchlorpheniramine Maleate in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Dexchlorpheniramine Maleate approved in United States?
Yes. FDA authorised it on 14 July 1981; FDA authorised it on 14 July 1981; FDA authorised it on 19 July 1982.
Who is the marketing authorisation holder for Dexchlorpheniramine Maleate in United States?
Marketing authorisation holder not available in our data.