FDA — authorised 18 October 1963
- Application: NDA013483
- Marketing authorisation holder: SCHERING PLOUGH
- Local brand name: DISOPHROL
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
🇺🇸 DEXBROMPHENIRAMINE MALEATE in United States
FDA authorised DEXBROMPHENIRAMINE MALEATE on 18 October 1963
Marketing authorisations
FDA — authorised 8 July 1986
- Application: NDA012394
- Marketing authorisation holder: SCHERING
- Local brand name: DISOPHROL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 January 1987
- Application: ANDA089116
- Marketing authorisation holder: COPLEY PHARM
- Local brand name: BROMPHERIL
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 30 September 1991
- Application: ANDA070770
- Marketing authorisation holder: SANDOZ
- Local brand name: DISOBROM
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 27 February 2013
- Application: ANDA078648
- Marketing authorisation holder: AVANTHI INC
- Local brand name: DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA
- Status: approved
DEXBROMPHENIRAMINE MALEATE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is DEXBROMPHENIRAMINE MALEATE approved in United States?
Yes. FDA authorised it on 18 October 1963; FDA authorised it on 8 July 1986; FDA authorised it on 22 January 1987.
Who is the marketing authorisation holder for DEXBROMPHENIRAMINE MALEATE in United States?
SCHERING PLOUGH holds the US marketing authorisation.