FDA — authorised 17 October 1961
- Application: NDA012649
- Marketing authorisation holder: MERCK
- Local brand name: PERIACTIN
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Cyproheptadine Hydrochloride in United States
FDA authorised Cyproheptadine Hydrochloride on 17 October 1961
Marketing authorisations
FDA — authorised 17 October 1961
- Status: approved
FDA — authorised 30 March 1962
- Application: NDA013220
- Marketing authorisation holder: MERCK
- Local brand name: PERIACTIN
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 23 April 1979
- Application: ANDA086678
- Marketing authorisation holder: MYLAN
- Local brand name: CYPROHEPTADINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 January 1980
- Application: ANDA087056
- Marketing authorisation holder: HERITAGE PHARMA
- Local brand name: CYPROHEPTADINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 April 1980
- Application: ANDA086833
- Marketing authorisation holder: ACTAVIS MID ATLANTIC
- Local brand name: CYPROHEPTADINE HYDROCHLORIDE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 14 October 1980
- Application: ANDA086737
- Marketing authorisation holder: KV PHARM
- Local brand name: CYPROHEPTADINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 February 1981
- Application: ANDA086808
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: CYPROHEPTADINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 May 1981
- Application: ANDA087405
- Marketing authorisation holder: SUPERPHARM
- Local brand name: CYPROHEPTADINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 July 1981
- Application: ANDA087129
- Marketing authorisation holder: ANVI
- Local brand name: CYPROHEPTADINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 September 1981
- Application: ANDA086580
- Marketing authorisation holder: WATSON LABS
- Local brand name: CYPROHEPTADINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 November 1982
- Application: ANDA087284
- Marketing authorisation holder: VITARINE
- Local brand name: CYPROHEPTADINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 May 1983
- Application: ANDA088212
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: CYPROHEPTADINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 July 1983
- Application: ANDA088205
- Marketing authorisation holder: PLIVA
- Local brand name: CYPROHEPTADINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 October 1983
- Application: ANDA088232
- Marketing authorisation holder: DURAMED PHARMS BARR
- Local brand name: CYPROHEPTADINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 July 1986
- Application: ANDA089057
- Marketing authorisation holder: HALSEY
- Local brand name: CYPROHEPTADINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 July 1986
- Application: ANDA089199
- Marketing authorisation holder: HALSEY
- Local brand name: CYPROHEPTADINE HYDROCHLORIDE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 21 December 1987
- Application: ANDA089021
- Marketing authorisation holder: NASKA
- Local brand name: CYPROHEPTADINE HYDROCHLORIDE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 30 September 2003
- Application: ANDA040537
- Marketing authorisation holder: MOUNTAIN
- Local brand name: CYPROHEPTADINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 May 2006
- Application: ANDA040644
- Marketing authorisation holder: KENTON
- Local brand name: CYPROHEPTADINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 June 2006
- Application: ANDA040668
- Marketing authorisation holder: RISING
- Local brand name: CYPROHEPTADINE HYDROCHLORIDE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 28 March 2013
- Application: ANDA091295
- Marketing authorisation holder: PHARM ASSOC
- Local brand name: CYPROHEPTADINE HYDROCHLORIDE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 23 September 2015
- Application: ANDA205087
- Marketing authorisation holder: INGENUS PHARMS LLC
- Local brand name: CYPROHEPTADINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 November 2016
- Application: ANDA206553
- Marketing authorisation holder: APPCO
- Local brand name: CYPROHEPTADINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 December 2016
- Application: ANDA204823
- Marketing authorisation holder: PATRIN
- Local brand name: CYPROHEPTADINE HYDROCHLORIDE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 31 January 2017
- Application: ANDA207555
- Marketing authorisation holder: RISING
- Local brand name: CYPROHEPTADINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 May 2017
- Application: ANDA208938
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: CYPROHEPTADINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 July 2017
- Application: ANDA203191
- Marketing authorisation holder: CHARTWELL MOLECULAR
- Local brand name: CYPROHEPTADINE HYDROCHLORIDE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 11 April 2018
- Application: ANDA209172
- Marketing authorisation holder: STRIDES PHARMA INTL
- Local brand name: CYPROHEPTADINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 October 2018
- Application: ANDA209108
- Marketing authorisation holder: ST JOHN PHARM
- Local brand name: CYPROHEPTADINE HYDROCHLORIDE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 12 April 2019
- Application: ANDA206676
- Marketing authorisation holder: REGCON HOLDINGS
- Local brand name: CYPROHEPTADINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 May 2019
- Application: ANDA212423
- Marketing authorisation holder: QUAGEN
- Local brand name: CYPROHEPTADINE HYDROCHLORIDE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 24 February 2021
- Application: ANDA212491
- Marketing authorisation holder: QUAGEN
- Local brand name: CYPROHEPTADINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 December 2021
- Application: ANDA205431
- Marketing authorisation holder: TRIS PHARMA INC
- Status: approved
FDA
- Application: ANDA085245
- Marketing authorisation holder: WATSON LABS
- Local brand name: CYPROHEPTADINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA087685
- Marketing authorisation holder: ASCOT
- Local brand name: CYPROHEPTADINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA087566
- Marketing authorisation holder: MD PHARM
- Local brand name: CYPROHEPTADINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA086165
- Marketing authorisation holder: WATSON LABS
- Local brand name: CYPROHEPTADINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
Cyproheptadine Hydrochloride in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Dermatology approved in United States
Frequently asked questions
Is Cyproheptadine Hydrochloride approved in United States?
Yes. FDA authorised it on 17 October 1961; FDA authorised it on 17 October 1961; FDA authorised it on 30 March 1962.
Who is the marketing authorisation holder for Cyproheptadine Hydrochloride in United States?
MERCK holds the US marketing authorisation.