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Details for New Drug Application (NDA): 077291

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NDA 077291 describes CYCLOBENZAPRINE HYDROCHLORIDE, which is a drug marketed by Oxford Pharms, Actavis Labs Fl Inc, Orit Labs Llc, Pliva, Sun Pharm Inds Ltd, Watson Labs, Frontida Biopharm, Aurobindo Pharma, Mylan Pharms Inc, Kvk Tech, Sandoz, Jubilant Cadista, Invagen Pharms, Twi Pharms Inc, and Vintage Pharms, and is included in eighteen NDAs. It is available from seventy 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-two suppliers are listed for this compound. There are two tentative approvals for this compound. Additional details are available on the cyclobenzaprine hydrochloride profile page.

Summary for NDA: 077291

Oxford Pharms
cyclobenzaprine hydrochloride
Therapeutic Class:Skeletal Muscle Relaxants

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength5MG
Approval Date:Feb 3, 2006TE:RLD:No

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