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Details for Generic Name: cevimeline hydrochloride

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Cevimeline hydrochloride is the generic ingredient in three branded drugs marketed by Apotex Inc, Pack Pharms Llc, Roxane, and Daiichi Sankyo, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for cevimeline hydrochloride. Four suppliers are listed for this compound.

Summary for Generic Name: cevimeline hydrochloride

Drug Master File Entries: see list4
Suppliers / Packaging: see list7
Therapeutic Class:Dental and Oral Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: cevimeline hydrochloride

Clinical Trials for: cevimeline hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pack Pharms Llc
cevimeline hydrochloride
CAPSULE;ORAL203775-001Jun 4, 2014RXNo<disabled><disabled>
Daiichi Sankyo
cevimeline hydrochloride
CAPSULE;ORAL020989-002Jan 11, 2000RXYes<disabled><disabled>
cevimeline hydrochloride
CAPSULE;ORAL091591-001Jul 8, 2013RXNo<disabled><disabled>
Apotex Inc
cevimeline hydrochloride
CAPSULE;ORAL091260-001Aug 25, 2011RXNo<disabled><disabled>
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Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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