FDA — authorised 31 May 1972
- Marketing authorisation holder: ALRA
- Status: approved
🇺🇸 Dimenhydrinate in United States
FDA authorised Dimenhydrinate on 31 May 1972
Marketing authorisations
FDA — authorised 31 May 1972
- Application: ANDA080715
- Marketing authorisation holder: ALRA
- Local brand name: DIMENHYDRINATE
- Indication: LIQUID — ORAL
- Status: approved
FDA — authorised 29 January 1974
- Application: ANDA080615
- Marketing authorisation holder: WATSON LABS TEVA
- Local brand name: DIMENHYDRINATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 18 August 1975
- Application: ANDA084316
- Marketing authorisation holder: WYETH AYERST
- Local brand name: DIMENHYDRINATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 13 September 1976
- Application: ANDA084767
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: DIMENHYDRINATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 5 July 1977
- Application: ANDA083531
- Marketing authorisation holder: WATSON LABS
- Local brand name: DIMENHYDRINATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 19 December 1977
- Application: ANDA085985
- Marketing authorisation holder: NEXGEN PHARMA INC
- Local brand name: DIMENHYDRINATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 December 1981
- Application: ANDA085166
- Marketing authorisation holder: WATSON LABS
- Local brand name: DIMENHYDRINATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 June 2004
- Application: ANDA040519
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: DIMENHYDRINATE
- Indication: INJECTABLE — INJECTION
- Status: approved
Dimenhydrinate in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Pain approved in United States
Frequently asked questions
Is Dimenhydrinate approved in United States?
Yes. FDA authorised it on 31 May 1972; FDA authorised it on 31 May 1972; FDA authorised it on 29 January 1974.
Who is the marketing authorisation holder for Dimenhydrinate in United States?
ALRA holds the US marketing authorisation.