FDA — authorised 19 November 1991
- Application: ANDA072854
- Marketing authorisation holder: AIPING PHARM INC
- Local brand name: CYCLOBENZAPRINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Cyclobenzaprine hydrochloride 2% in United States
FDA authorised Cyclobenzaprine hydrochloride 2% on 19 November 1991
Marketing authorisations
FDA — authorised 26 February 1993
- Application: ANDA073683
- Marketing authorisation holder: SANDOZ
- Local brand name: CYCLOBENZAPRINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 November 1994
- Application: ANDA074436
- Marketing authorisation holder: WATSON LABS
- Local brand name: CYCLOBENZAPRINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 May 1995
- Application: ANDA073541
- Marketing authorisation holder: TP ANDA HOLDINGS
- Local brand name: CYCLOBENZAPRINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 September 1995
- Application: ANDA074421
- Marketing authorisation holder: PLIVA
- Local brand name: CYCLOBENZAPRINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 October 2005
- Application: ANDA077209
- Marketing authorisation holder: OXFORD PHARMS
- Local brand name: CYCLOBENZAPRINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 April 2006
- Application: ANDA077563
- Marketing authorisation holder: JUBILANT CADISTA
- Local brand name: CYCLOBENZAPRINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 February 2007
- Application: ANDA077797
- Marketing authorisation holder: PRINSTON INC
- Local brand name: CYCLOBENZAPRINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 April 2008
- Application: ANDA078218
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: CYCLOBENZAPRINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 May 2008
- Application: ANDA078722
- Marketing authorisation holder: SUN PHARM INDS LTD
- Local brand name: CYCLOBENZAPRINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 September 2008
- Application: ANDA078643
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: CYCLOBENZAPRINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 July 2010
- Application: ANDA090478
- Marketing authorisation holder: INVAGEN PHARMS
- Local brand name: CYCLOBENZAPRINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 February 2011
- Application: ANDA078048
- Marketing authorisation holder: KVK TECH
- Local brand name: CYCLOBENZAPRINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 January 2013
- Application: ANDA091281
- Marketing authorisation holder: TWI PHARMS INC
- Local brand name: CYCLOBENZAPRINE HYDROCHLORIDE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 24 July 2018
- Application: ANDA206703
- Marketing authorisation holder: APOTEX
- Local brand name: CYCLOBENZAPRINE HYDROCHLORIDE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 6 July 2020
- Application: ANDA213324
- Marketing authorisation holder: UNICHEM
- Local brand name: CYCLOBENZAPRINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 July 2024
- Application: ANDA207314
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: CYCLOBENZAPRINE HYDROCHLORIDE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 27 August 2024
- Application: ANDA214732
- Marketing authorisation holder: NOVAST LABS
- Local brand name: CYCLOBENZAPRINE HYDROCHLORIDE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 12 September 2024
- Application: ANDA218936
- Marketing authorisation holder: RISING
- Local brand name: CYCLOBENZAPRINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 August 2025
- Application: NDA219428
- Marketing authorisation holder: TONIX
- Local brand name: TONMYA
- Indication: TABLET — SUBLINGUAL
- Status: approved
FDA
- Application: ANDA090864
- Marketing authorisation holder: PAR PHARM INC
- Local brand name: CYCLOBENZAPRINE HYDROCHLORIDE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
Other Musculoskeletal/Pain Management approved in United States
Frequently asked questions
Is Cyclobenzaprine hydrochloride 2% approved in United States?
Yes. FDA authorised it on 19 November 1991; FDA authorised it on 26 February 1993; FDA authorised it on 30 November 1994.
Who is the marketing authorisation holder for Cyclobenzaprine hydrochloride 2% in United States?
AIPING PHARM INC holds the US marketing authorisation.