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Details for New Drug Application (NDA): 073144

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NDA 073144 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 sixty-nine 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-one 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: 073144

Pharmacology for NDA: 073144

Suppliers and Packaging for NDA: 073144

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
cyclobenzaprine hydrochloride
TABLET;ORAL 073144 ANDA Mylan Pharmaceuticals Inc. 0378-0751 0378-0751-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0751-01)
cyclobenzaprine hydrochloride
TABLET;ORAL 073144 ANDA Mylan Pharmaceuticals Inc. 0378-0751 0378-0751-10 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0751-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:May 30, 1991TE:ABRLD:Yes

Summary for product number 002

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

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength7.5MG
Approval Date:Mar 25, 2013TE:ABRLD:No

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