FDA — authorised 24 August 1984
- Application: NDA019279
- Marketing authorisation holder: ROBINS AH
- Local brand name: DIMETANE-DX
- Indication: SYRUP — ORAL
- Status: approved
🇺🇸 Dimetane-Dx in United States
FDA authorised Dimetane-Dx on 24 August 1984
Marketing authorisations
FDA — authorised 15 July 2014
- Application: ANDA205292
- Marketing authorisation holder: PADAGIS US
- Status: approved
FDA — authorised 20 September 2016
- Application: ANDA203375
- Marketing authorisation holder: ACELLA
- Status: approved
FDA — authorised 4 December 2018
- Application: ANDA207676
- Marketing authorisation holder: DR REDDYS LABS SA
- Status: approved
FDA — authorised 16 June 2020
- Application: ANDA211170
- Marketing authorisation holder: HIBROW HLTHCARE
- Status: approved
FDA — authorised 14 July 2020
- Application: ANDA210647
- Marketing authorisation holder: ALKEM LABS LTD
- Status: approved
Dimetane-Dx 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 Dimetane-Dx approved in United States?
Yes. FDA authorised it on 24 August 1984; FDA authorised it on 15 July 2014; FDA authorised it on 20 September 2016.
Who is the marketing authorisation holder for Dimetane-Dx in United States?
ROBINS AH holds the US marketing authorisation.