FDA — authorised 10 November 1942
- Application: NDA021171
- Marketing authorisation holder: HOSPIRA
- Local brand name: DEMEROL
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Meperidine Hydrochloride Preservative Free in United States
FDA authorised Meperidine Hydrochloride Preservative Free on 10 November 1942
Marketing authorisations
FDA — authorised 10 November 1942
- Application: NDA005010
- Marketing authorisation holder: QUAGEN
- Local brand name: DEMEROL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 November 1961
- Application: NDA011730
- Marketing authorisation holder: HIKMA
- Local brand name: MEPERGAN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 26 April 1972
- Application: ANDA080455
- Marketing authorisation holder: WEST-WARD PHARMS INT
- Local brand name: MEPERIDINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 31 July 1973
- Application: ANDA080454
- Marketing authorisation holder: WYETH AYERST
- Local brand name: MEPERIDINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 January 1975
- Application: ANDA080445
- Marketing authorisation holder: WEST-WARD PHARMS INT
- Local brand name: MEPERIDINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
The FDA approved Meperidine Hydrochloride Preservative Free, a prescription medication, for marketing in the United States. The approval was granted to WEST-WARD PHARMS INT on 11 October 2024, under the application number ANDA080445. The medication is a preservative-free formulation of Meperidine Hydrochloride, which is used for pain relief.
FDA — authorised 15 October 1976
- Application: ANDA080448
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: MEPERIDINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 June 1984
- Application: ANDA088280
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: MEPERIDINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 15 June 1984
- Application: ANDA088281
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: MEPERIDINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 15 June 1984
- Application: ANDA088279
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: MEPERIDINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 15 June 1984
- Application: ANDA088282
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: MEPERIDINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 2 July 1984
- Application: ANDA088639
- Marketing authorisation holder: BARR
- Local brand name: MEPERIDINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 August 1984
- Application: ANDA088432
- Marketing authorisation holder: ICU MEDICAL INC
- Local brand name: MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 19 September 1984
- Application: ANDA088640
- Marketing authorisation holder: BARR
- Local brand name: MEPERIDINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 January 1985
- Application: ANDA088744
- Marketing authorisation holder: HIKMA
- Local brand name: MEPERIDINE HYDROCHLORIDE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 17 March 1992
- Application: ANDA073445
- Marketing authorisation holder: WATSON LABS
- Local brand name: MEPERIDINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 17 March 1992
- Application: ANDA073444
- Marketing authorisation holder: WATSON LABS
- Local brand name: MEPERIDINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 17 March 1992
- Application: ANDA073443
- Marketing authorisation holder: WATSON LABS
- Local brand name: MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 July 1993
- Application: ANDA081002
- Marketing authorisation holder: WEST-WARD PHARMS INT
- Local brand name: MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 August 1993
- Application: ANDA081309
- Marketing authorisation holder: INTL MEDICATION
- Local brand name: MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 12 March 1997
- Application: ANDA040110
- Marketing authorisation holder: HIKMA
- Local brand name: MEPERIDINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 March 1999
- Application: ANDA040305
- Marketing authorisation holder: HOSPIRA
- Local brand name: MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 28 May 1999
- Application: ANDA040331
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: MEPERIDINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 October 1999
- Application: ANDA040318
- Marketing authorisation holder: DURAMED PHARMS BARR
- Local brand name: MEPERIDINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 June 2000
- Application: ANDA040352
- Marketing authorisation holder: SPECGX LLC
- Local brand name: MEPERIDINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 August 2002
- Application: ANDA040446
- Marketing authorisation holder: SUN PHARM INDS INC
- Local brand name: MEPERIDINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 June 2009
- Application: ANDA040893
- Marketing authorisation holder: GENUS
- Local brand name: MEPERIDINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA080385
- Marketing authorisation holder: ABBOTT
- Local brand name: MEPERIDINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA080389
- Marketing authorisation holder: ABBOTT
- Local brand name: MEPERIDINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA080388
- Marketing authorisation holder: ABBOTT
- Local brand name: MEPERIDINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA089781
- Marketing authorisation holder: IGI LABS INC
- Local brand name: MEPERIDINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA089782
- Marketing authorisation holder: IGI LABS INC
- Local brand name: MEPERIDINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA089783
- Marketing authorisation holder: IGI LABS INC
- Local brand name: MEPERIDINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA089784
- Marketing authorisation holder: IGI LABS INC
- Local brand name: MEPERIDINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA089785
- Marketing authorisation holder: IGI LABS INC
- Local brand name: MEPERIDINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA089786
- Marketing authorisation holder: IGI LABS INC
- Local brand name: MEPERIDINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA089787
- Marketing authorisation holder: IGI LABS INC
- Local brand name: MEPERIDINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA089788
- Marketing authorisation holder: IGI LABS INC
- Local brand name: MEPERIDINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA080387
- Marketing authorisation holder: ABBOTT
- Local brand name: MEPERIDINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA080386
- Marketing authorisation holder: ABBOTT
- Local brand name: MEPERIDINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
Meperidine Hydrochloride Preservative Free 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 Meperidine Hydrochloride Preservative Free approved in United States?
Yes. FDA authorised it on 10 November 1942; FDA authorised it on 10 November 1942; FDA authorised it on 13 November 1961.
Who is the marketing authorisation holder for Meperidine Hydrochloride Preservative Free in United States?
HOSPIRA holds the US marketing authorisation.