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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

Pharmacology for Ingredient: cevimeline hydrochloride

Clinical Trials for: cevimeline hydrochloride

Study of the Effectiveness of Cevimeline on Oral Health in Patients With Radiation Induced Xerostomia
Status: Completed Condition: Xerostomia

Crossover Bioequivalence Study of Cevimeline 30 mg Capsules Under Fed Conditions
Status: Completed Condition: Dry Mouth

Efficacy of Cevimeline Versus Pilocarpine in the Secretion of Saliva
Status: Completed Condition: Dry Mouth

Crossover Bioequivalence Study of Cevimeline 30 mg Capsules Under Fasted Conditions
Status: Completed Condition: Dry Mouth

Cevimeline in Treating Patients With Dry Mouth Caused by Radiation Therapy for Head and Neck Cancer
Status: Completed Condition: Head and Neck Cancer; Oral Complications; Radiation Toxicity

Courtesy of
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apotex Inc
cevimeline hydrochloride
CAPSULE;ORAL091260-001Aug 25, 2011RXNo<disabled><disabled>
cevimeline hydrochloride
CAPSULE;ORAL091591-001Jul 8, 2013RXNo<disabled><disabled>
Daiichi Sankyo
cevimeline hydrochloride
CAPSULE;ORAL020989-002Jan 11, 2000RXYes<disabled><disabled>
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ISSN: 2162-2639

Preferred citation:

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

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