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Generated: December 10, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078218

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NDA 078218 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-five 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. Seventy-seven suppliers are listed for this compound. Additional details are available on the cyclobenzaprine hydrochloride profile page.

Summary for 078218

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Skeletal Muscle Relaxants
Formulation / Manufacturing:see details

Pharmacology for NDA: 078218

Suppliers and Packaging for NDA: 078218

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CYCLOBENZAPRINE HYDROCHLORIDE cyclobenzaprine hydrochloride TABLET;ORAL 078218 ANDA Blenheim Pharmacal, Inc. 10544-159 10544-159-90 90 TABLET in 1 BOTTLE (10544-159-90)
CYCLOBENZAPRINE HYDROCHLORIDE cyclobenzaprine hydrochloride TABLET;ORAL 078218 ANDA Blenheim Pharmacal, Inc. 10544-159 10544-159-15 15 TABLET in 1 BOTTLE (10544-159-15)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Apr 18, 2008TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Jun 19, 2015TE:ABRLD:No


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McKinsey
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Julphar

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