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Generated: February 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 071611

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NDA 071611 describes CYCLOBENZAPRINE HYDROCHLORIDE, which is a drug marketed by Twi Pharms Inc, Actavis Labs Fl Inc, Aurobindo Pharma, Frontida Biopharm, Invagen Pharms, Jubilant Cadista, Kvk Tech, Mylan Pharms Inc, Orit Labs Llc, Oxford Pharms, Pliva, Prinston Inc, Rubicon Res Pvt Ltd, Sandoz, Sun Pharm Inds Ltd, Upsher-smith Labs, and Watson Labs, and is included in eighteen NDAs. It is available from seventy-eight suppliers. Additional details are available on the CYCLOBENZAPRINE HYDROCHLORIDE profile page.

The generic ingredient in CYCLOBENZAPRINE HYDROCHLORIDE is cyclobenzaprine hydrochloride. There are fifteen drug master file entries for this compound. Eighty suppliers are listed for this compound. Additional details are available on the cyclobenzaprine hydrochloride profile page.
Summary for 071611
Tradename:CYCLOBENZAPRINE HYDROCHLORIDE
Applicant:Actavis Labs Fl Inc
Ingredient:cyclobenzaprine hydrochloride
Patents:0
Therapeutic Class:Skeletal Muscle Relaxants
Formulation / Manufacturing:see details
Pharmacology for NDA: 071611
Suppliers and Packaging for NDA: 071611
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CYCLOBENZAPRINE HYDROCHLORIDE cyclobenzaprine hydrochloride TABLET;ORAL 071611 ANDA Liberty Pharmaceuticals, Inc. 0440-1350 N 0440-1350-09
CYCLOBENZAPRINE HYDROCHLORIDE cyclobenzaprine hydrochloride TABLET;ORAL 071611 ANDA Liberty Pharmaceuticals, Inc. 0440-7350 N 0440-7350-81

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:May 3, 1989TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Feb 3, 2006TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength7.5MG
Approval Date:Feb 3, 2006TE:ABRLD:No

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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