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CYCLOBENZAPRINE

 
 
Content specific to this active ingredient…

Drug Information
Prescribing and patient information from leading authorities

Drug Master Files
Type 2 master files on file at the FDA

Safety Information
For prescription drugs containing this active ingredient

Exclusivity
Patent and market exclusivity data

Federal Register
FR search results for this API

FDA Approved Labelling
Information found in this drug's package inserts

Research Links
Chemical identification and research citations

Title 21 Code of Federal Regulations
FDA regulations for this API

 
 
 
 
 
 
 
 

 


 

FDA Approval Activities for this Drug…

Flexeril (cyclobenzaprine HCL) Tablets, 5 mg, McNeil Consumer and Specialty NDA 17-821/S-045 CYCLOBENZAPRINE HYDROCHLORIDE Tablet; 10MG CYCLOBENZAPRINE HCL Geneva | 073683 CYCLOBENZAPRINE HYDROCHLORIDE Tablet; 10MG CYCLOBENZAPRINE HCL Geneva TECH | 073541 CYCLOBENZAPRINE HYDROCHLORIDE Tablet; 10MG CYCLOBENZAPRINE HCL HALSEY | 017821 CYCLOBENZAPRINE HYDROCHLORIDE Tablet; 10MG FLEXERIL MCNEIL CONS SPECLT | 017821 CYCLOBENZAPRINE HYDROCHLORIDE Tablet; 5MG FLEXERIL MCNEIL CONS SPECLT | 073144 CYCLOBENZAPRINE HYDROCHLORIDE Tablet; 10MG CYCLOBENZAPRINE HCL Mylan | 074421 CYCLOBENZAPRINE HYDROCHLORIDE Tablet; 10MG CYCLOBENZAPRINE HCL Pliva | 073143 CYCLOBENZAPRINE HYDROCHLORIDE Tablet; 10MG CYCLOBENZAPRINE HCL Watson | 074436 CYCLOBENZAPRINE HYDROCHLORIDE Tablet; 10MG CYCLOBENZAPRINE HCL Watson | 071611 CYCLOBENZAPRINE HYDROCHLORIDE Tablet; 10MG CYCLOBENZAPRINE HCL Watson | Cyclobenzaprine Hydrochloride Tablets, Mylan Pharma, Tentative Approval | Cyclobenzaprine Hydrochloride Tablets, Amide Pharma, Approval | Cyclobenzaprine Hydrochloride Tablets, Amide Pharma, Tentative Approval | Cyclobenzaprine Hydrochloride Tablets, Mylan Pharma, New Strength | Cyclobenzaprine Hydrochloride Tablets, Watson Labs, New Strength | Cyclobenzaprine Hydrochloride Tablets, Sandoz, Inc., New Strength | Cyclobenzaprine Hydrochloride Tablets, Amide Pharma, ApprovalHospira, Approval | Cyclobenzaprine Hydrochloride Tablets, Mutual Pharma, New Dosage | Cyclobenzaprine Hydrochloride Tablets, Jubilant Pharma, Approval | AMRIX (cyclobenzaprine hydrochloride) Extended-Release Capsules, ECR Pharma, Approval | AMRIX (cyclobenzaprine hydrochloride) Extended-Release Capsules, Anesta AG, Labeling Revision | Cyclobenzaprine Hydrochloride Tablets, Amneal Pharma, Approval | Cyclobenzaprine Hydrochloride Tablets, Ranbaxy, Inc., Approval | Cyclobenzaprine Hydrochloride Tablets, Aurobindo Pharma USA, Inc., Approval | Cyclobenzaprine Hydrochloride Tablets, Aurobindo Pharma, Approval | Cyclobenzaprine Hydrochloride Tablets, Invagen Pharmaceuticals, Inc., Approval | Cyclobenzaprine Hydrochloride Tablets, KVK-Tech, Inc., Approval | Cyclobenzaprine Hydrochloride Extended-Release Capsules, Mylan Pharmaceuticals, Inc., Tentative Approval | Cyclobenzaprine Hydrochloride Extended-Release Capsules, Mylan Pharmaceuticals Inc., Approval

^ FDA's latest approval appears at the bottom of this list. ^

                                                                   

 

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