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Last Updated: October 31, 2024

Details for New Drug Application (NDA): 091260

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NDA 091260 describes CEVIMELINE HYDROCHLORIDE, which is a drug marketed by Apotex Inc, Aurobindo Pharma, Bionpharma, Hikma, Novel Labs Inc, Rising, and Rubicon, and is included in seven NDAs. It is available from seven suppliers. Additional details are available on the CEVIMELINE HYDROCHLORIDE profile page.

The generic ingredient in CEVIMELINE HYDROCHLORIDE is cevimeline hydrochloride. There are four drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the cevimeline hydrochloride profile page.

Summary for 091260

Tradename:	CEVIMELINE HYDROCHLORIDE
Applicant:	Apotex Inc
Ingredient:	cevimeline hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	30MG
Approval Date:	Aug 25, 2011	TE:		RLD:	No

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