Last Updated: September 24, 2026

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, Macleods Pharms, Novel Labs Inc, Rising, Rubicon Research, and Zydus Lifesciences, and is included in nine NDAs. It is available from twelve suppliers. Additional details are available on the CEVIMELINE HYDROCHLORIDE profile page.

The generic ingredient in CEVIMELINE HYDROCHLORIDE is cevimeline hydrochloride. There is one drug master file entry for this compound. Fourteen 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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