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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 091281


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NDA 091281 describes CYCLOBENZAPRINE HYDROCHLORIDE, which is a drug marketed by Apotex, Twi Pharms Inc, Actavis Labs Fl Inc, Anda Repository, Aurobindo Pharma, Chartwell Rx, Invagen Pharms, Jubilant Cadista, Kvk Tech, Oxford Pharms, Pliva, Prinston Inc, Rising, Rubicon, Sandoz, Sun Pharm Inds Ltd, Unichem, and Watson Labs, and is included in twenty NDAs. It is available from fifty-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. Fifty-six suppliers are listed for this compound. Additional details are available on the cyclobenzaprine hydrochloride profile page.
Summary for 091281
Tradename:CYCLOBENZAPRINE HYDROCHLORIDE
Applicant:Twi Pharms Inc
Ingredient:cyclobenzaprine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 091281
Suppliers and Packaging for NDA: 091281
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CYCLOBENZAPRINE HYDROCHLORIDE cyclobenzaprine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 091281 ANDA TWi Pharmaceuticals, Inc. 24979-035 24979-035-04 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (24979-035-04)
CYCLOBENZAPRINE HYDROCHLORIDE cyclobenzaprine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 091281 ANDA TWi Pharmaceuticals, Inc. 24979-036 24979-036-04 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (24979-036-04)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength15MG
Approval Date:Jan 31, 2013TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength30MG
Approval Date:Jan 31, 2013TE:ABRLD:No

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