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Details for New Drug Application (NDA): 074421

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NDA 074421 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, Upsher-smith Labs, Jubilant Cadista, Invagen Pharms, Twi Pharms Inc, Sandoz, and Prinston Inc, and is included in eighteen NDAs. It is available from seventy-one 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-three 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: 074421

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
TABLET;ORAL 074421 ANDA MedVantx, Inc. 66116-527 66116-527-30 30 TABLET, FILM COATED in 1 BOTTLE (66116-527-30)
cyclobenzaprine hydrochloride
TABLET;ORAL 074421 ANDA RedPharm Drug Inc. 67296-0106 67296-0106-1 15 TABLET, FILM COATED in 1 BOTTLE (67296-0106-1)

Summary for product number 001

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

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