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Generated: June 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091260

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NDA 091260 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 five 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. Eight 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
Therapeutic Class:Dental and Oral Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 091260
Suppliers and Packaging for NDA: 091260
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEVIMELINE HYDROCHLORIDE cevimeline hydrochloride CAPSULE;ORAL 091260 ANDA Apotex Corp. 60505-3145 N 60505-3145-1
CEVIMELINE HYDROCHLORIDE cevimeline hydrochloride CAPSULE;ORAL 091260 ANDA Apotex Corp. 60505-3145 N 60505-3145-5

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength30MG
Approval Date:Aug 25, 2011TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Fuji
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Chubb
Cantor Fitzgerald
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Colorcon

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