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Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074421

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NDA 074421 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 074421

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

Pharmacology for NDA: 074421

Suppliers and Packaging for NDA: 074421

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CYCLOBENZAPRINE HYDROCHLORIDE cyclobenzaprine hydrochloride TABLET;ORAL 074421 ANDA MedVantx, Inc. 66116-527 66116-527-30 30 TABLET, FILM COATED in 1 BOTTLE (66116-527-30)
CYCLOBENZAPRINE HYDROCHLORIDE cyclobenzaprine hydrochloride TABLET;ORAL 074421 ANDA RedPharm Drug Inc. 67296-0106 67296-0106-3 30 TABLET, FILM COATED in 1 BOTTLE (67296-0106-3)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Sep 29, 1995TE:ABRLD:No


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