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Generated: May 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090478

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NDA 090478 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 090478
Tradename:CYCLOBENZAPRINE HYDROCHLORIDE
Applicant:Invagen Pharms
Ingredient:cyclobenzaprine hydrochloride
Patents:0
Therapeutic Class:Skeletal Muscle Relaxants
Formulation / Manufacturing:see details
Pharmacology for NDA: 090478
Suppliers and Packaging for NDA: 090478
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CYCLOBENZAPRINE HYDROCHLORIDE cyclobenzaprine hydrochloride TABLET;ORAL 090478 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-8084 N 0615-8084-05
CYCLOBENZAPRINE HYDROCHLORIDE cyclobenzaprine hydrochloride TABLET;ORAL 090478 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-8084 N 0615-8084-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Jul 23, 2010TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Jul 23, 2010TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Teva
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Express Scripts
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US Army
Cantor Fitzgerald
Accenture

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