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Generated: February 17, 2019

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Details for New Drug Application (NDA): 203775

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NDA 203775 describes CEVIMELINE HYDROCHLORIDE, which is a drug marketed by Apotex Inc, Novel Labs Inc, Rising Pharms, and West-ward Pharms Int, and is included in four NDAs. It is available from three 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. Five suppliers are listed for this compound. Additional details are available on the cevimeline hydrochloride profile page.
Summary for 203775
Applicant:Rising Pharms
Ingredient:cevimeline hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 203775
Suppliers and Packaging for NDA: 203775
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEVIMELINE HYDROCHLORIDE cevimeline hydrochloride CAPSULE;ORAL 203775 ANDA Rising Pharmaceuticals, Inc. 16571-657 16571-657-10 100 CAPSULE in 1 BOTTLE (16571-657-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength30MG
Approval Date:Jun 4, 2014TE:ABRLD:No

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