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Citi
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Generated: May 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 073144

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NDA 073144 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 eighty 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-two suppliers are listed for this compound. Additional details are available on the cyclobenzaprine hydrochloride profile page.
Summary for 073144
Tradename:CYCLOBENZAPRINE HYDROCHLORIDE
Applicant:Mylan Pharms Inc
Ingredient:cyclobenzaprine hydrochloride
Patents:0
Therapeutic Class:Skeletal Muscle Relaxants
Formulation / Manufacturing:see details
Pharmacology for NDA: 073144
Suppliers and Packaging for NDA: 073144
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CYCLOBENZAPRINE HYDROCHLORIDE cyclobenzaprine hydrochloride TABLET;ORAL 073144 ANDA Mylan Pharmaceuticals Inc. 0378-0751 N 0378-0751-01
CYCLOBENZAPRINE HYDROCHLORIDE cyclobenzaprine hydrochloride TABLET;ORAL 073144 ANDA Mylan Pharmaceuticals Inc. 0378-0751 N 0378-0751-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:May 30, 1991TE: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:Mar 25, 2013TE:ABRLD:No

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Farmers Insurance
Daiichi Sankyo
Mallinckrodt
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US Department of Justice
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