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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Fish and Richardson
Chinese Patent Office
US Army
Johnson and Johnson
Farmers Insurance

Generated: April 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091591

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NDA 091591 describes CEVIMELINE HYDROCHLORIDE, which is a drug marketed by Apotex Inc, Novel Labs Inc, Rising Pharms Inc, and West-ward Pharms Int, and is included in four NDAs. It is available from six 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. Nine suppliers are listed for this compound. Additional details are available on the cevimeline hydrochloride profile page.
Summary for 091591
Applicant:West-ward Pharms Int
Ingredient:cevimeline hydrochloride
Therapeutic Class:Dental and Oral Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 091591
Suppliers and Packaging for NDA: 091591
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEVIMELINE HYDROCHLORIDE cevimeline hydrochloride CAPSULE;ORAL 091591 ANDA West-Ward Pharmaceuticals Corp. 0054-0334 N 0054-0334-25
CEVIMELINE HYDROCHLORIDE cevimeline hydrochloride CAPSULE;ORAL 091591 ANDA Avera McKennan Hospital 69189-0399 E 69189-0399-1

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength30MG
Approval Date:Jul 8, 2013TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Daiichi Sankyo
Federal Trade Commission

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