Tools / Drug approvals and letters / Drugs Cyclobenzaprine Hydrochloride Relieves muscle spasm associated with acute, painful musculoskeletal conditions. Sold as Flexeril, Amrix, Tonmya. Every FDA application for this active ingredient: 3 branded and 24 generic.
As of Nov 15, 2026, FDA lists 27 applications for Cyclobenzaprine Hydrochloride (sold as Flexeril, Amrix, Tonmya), first approved Aug 26, 1977, with 1 new use approved and 0 published complete response letters.
First approved : Aug 26, 1977 Applications : 27 New uses approved : 1 Complete response letters : 0 Medicare spending, 2025 : $68.8M
Medicare Spending CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name Product Part Spending, 2025 Change Beneficiaries Cyclobenzaprine HCl Part D $67.3M +9% 2,710,838 Cyclobenzaprine HCl ER Part D $985K -47% 1,218 Amrix Part D $249K -44% 22 Tonmya Part D $197K New 133
What Pharmacies Pay Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change CYCLOBENZAPRINE 10 MG TABLET: $0.017 per unit Generic · -7% in a year CYCLOBENZAPRINE 5 MG TABLET: $0.022 per unit Generic · +2% in a year CYCLOBENZAPRINE 7.5 MG TABLET: $0.293 per unit Generic · -11% in a year CYCLOBENZAPRINE ER 15 MG CAP: $1.18 per unit Generic · -5% in a year CYCLOBENZAPRINE ER 30 MG CAP: $1.47 per unit Generic · -47% in a year AMRIX ER 15 MG CAPSULE: $66.23 per unit Brand · +9% in a year AMRIX ER 30 MG CAPSULE: $66.57 per unit Brand · +9% in a year TONMYA 2.8 MG TABLET SL: $29.59 per unit Brand · new this year Clinical Trials 12 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all Study Phase Status Posted Phenotype-based Model for Managing Chronic Post-treatment Pain Among Head and Neck Cancer Survivors: a Pilot Study Chronic Postsurgical Pain, Chronic Post Cancer Surgery Pain · Shaukat Khanum Memorial Cancer Hospital & Research Centre Phase 2 Recruiting Nov 5, 2026 Effectiveness of Phenotype-based Pain Management Guidelines for Head and Neck Cancer Related Pain: a Pilot Study Cancer Pain, Orofacial Pain · Shaukat Khanum Memorial Cancer Hospital & Research Centre Phase 2 Recruiting Nov 5, 2026 Epidural Analgesia Versus Opioid-sparing Analgesia for Open Ventral Hernia Repair With Transversus Abdominis Release Ventral Hernia, Ventral Hernia Repair · Northwestern University Phase 4 Recruiting Sep 24, 2026 Cyclobenzaprine for Postoperative Pain in Minimally Invasive Hysterectomy Minimally Invasive Surgical Procedures, Abnormal Uterine Bleeding, Unspecified · Christiana Care Health Services Phase 4 Not yet recruiting Jun 24, 2026 A Study to Evaluate TNX-102 SL Monotherapy Versus Placebo in Participants With Major Depressive Disorder (MDD) Major Depressive Episode (MDE), Major Depressive Disorder (MDD) · Tonix Pharmaceuticals, Inc. Phase 2 Recruiting Jun 2, 2026 A Phase 1, Open-Label, Parallel-Group, Single-Dose Study To Compare The Pharmakokinetics Of TNX-102 SL (Cyclobenzaprine Hydrochloride Sublingual Tablet) In Non-Elderly Versus Elderly Participants Pharmakokinetic, Open Label · Tonix Pharmaceuticals, Inc. Phase 1 Active, not recruiting Feb 17, 2026 Comparing Adjuvant Treatments for High Tone Pelvic Floor Dysfunction High Tone Pelvic Floor Dysfunction · University of Michigan Phase 2 / Phase 3 Recruiting Feb 11, 2026 An Artificial Intelligence Driven Approach to Optimize Patient Selection for a Transitional Pain Service Postsurgical Pain Management, Postsurgical Pain, Chronic · University of California, San Francisco Phase 3 Not yet recruiting Dec 22, 2025
Applications NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history Approved Application Sponsor Supplements Marketing Aug 26, 1977 Flexeril NDA 17821 · New molecular entity 31 Discontinued Feb 29, 1988 Cyclobenzaprine Hydrochloride ANDA 71611 33 Marketed May 31, 1991 Cyclobenzaprine Hydrochloride ANDA 73144 15 Discontinued Nov 19, 1991 Cyclobenzaprine Hydrochloride ANDA 72854 14 Marketed Nov 27, 1991 Cyclobenzaprine Hydrochloride ANDA 73143 7 Discontinued Feb 26, 1993 Cyclobenzaprine Hydrochloride ANDA 73683 4 Discontinued Nov 30, 1994 Cyclobenzaprine Hydrochloride ANDA 74436 4 Discontinued May 23, 1995 Cyclobenzaprine Hydrochloride ANDA 73541 5 Marketed Sep 29, 1995 Cyclobenzaprine Hydrochloride ANDA 74421 8 Discontinued Oct 4, 2005 Cyclobenzaprine Hydrochloride ANDA 77209 1 Marketed Apr 19, 2006 Cyclobenzaprine Hydrochloride ANDA 77563 1 Marketed Feb 1, 2007 Amrix NDA 21777 · New dosage form 8 Marketed Feb 28, 2007 Cyclobenzaprine Hydrochloride ANDA 77797 3 Marketed Apr 18, 2008 Cyclobenzaprine Hydrochloride ANDA 78218 2 Marketed May 12, 2008 Cyclobenzaprine Hydrochloride ANDA 78722 1 Discontinued Sep 26, 2008 Cyclobenzaprine Hydrochloride ANDA 78643 1 Marketed Jul 23, 2010 Cyclobenzaprine Hydrochloride ANDA 90478 1 Marketed Feb 28, 2011 Cyclobenzaprine Hydrochloride ANDA 78048 1 Marketed Jan 31, 2013 Cyclobenzaprine Hydrochloride ANDA 91281 4 Marketed May 31, 2017 Cyclobenzaprine Hydrochloride ANDA 208170 0 Marketed Jul 24, 2018 Cyclobenzaprine Hydrochloride ANDA 206703 1 Discontinued Jul 6, 2020 Cyclobenzaprine Hydrochloride ANDA 213324 0 Marketed Jul 22, 2024 Cyclobenzaprine Hydrochloride ANDA 207314 0 Marketed Aug 27, 2024 Cyclobenzaprine Hydrochloride ANDA 214732 0 Marketed Sep 12, 2024 Cyclobenzaprine Hydrochloride ANDA 218936 0 Marketed Aug 15, 2025 Tonmya NDA 219428 · New dosage form 0 Marketed — Cyclobenzaprine Hydrochloride ANDA 90864 0 Discontinued
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
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