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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 073143

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NDA 073143 describes CYCLOBENZAPRINE HYDROCHLORIDE, which is a drug marketed by Apotex, Macleods Pharms Ltd, Novast Labs, Twi Pharms Inc, Actavis Labs Fl Inc, Aiping Pharm Inc, Anda Repository, Aurobindo Pharma, Chartwell Rx, Graviti Pharms, 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-three NDAs. It is available from fifty-six 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-eight suppliers are listed for this compound. Additional details are available on the cyclobenzaprine hydrochloride profile page.

Summary for 073143

Tradename:	CYCLOBENZAPRINE HYDROCHLORIDE
Applicant:	Watson Labs
Ingredient:	cyclobenzaprine hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Nov 27, 1991	TE:		RLD:	No

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