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Last Updated: November 15, 2019

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 Apotex Inc, Twi Pharms Inc, Actavis Labs Fl Inc, Anda Repository, Aurobindo Pharma, Invagen Pharms, Jubilant Cadista, Kvk Tech, Mylan Pharms Inc, Orit Labs Llc, Oxford Pharms, Pliva, Prinston Inc, Rubicon, Sandoz, Sun Pharm Inds Ltd, Upsher Smith Labs, and Watson Labs, and is included in nineteen NDAs. It is available from sixty-five suppliers. Additional details are available on the CYCLOBENZAPRINE HYDROCHLORIDE profile page.

The generic ingredient in CYCLOBENZAPRINE HYDROCHLORIDE is cyclobenzaprine hydrochloride. There are sixteen drug master file entries for this compound. Sixty-seven 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
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 0615-8084-05 15 TABLET, FILM COATED in 1 BLISTER PACK (0615-8084-05)
CYCLOBENZAPRINE HYDROCHLORIDE cyclobenzaprine hydrochloride TABLET;ORAL 090478 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-8084 0615-8084-30 6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-8084-30) > 5 TABLET, FILM COATED in 1 BLISTER PACK

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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