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Generated: May 23, 2017

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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 Novel Labs Inc, Apotex Inc, Pack Pharms Llc, 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. Nine suppliers are listed for this compound. Additional details are available on the cevimeline hydrochloride profile page.

Summary for NDA: 203775

Therapeutic Class:Dental and Oral Agents
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
CAPSULE;ORAL 203775 ANDA Pack Pharmaceuticals, LLC 16571-657 16571-657-10 100 CAPSULE in 1 BOTTLE (16571-657-10)
cevimeline hydrochloride
CAPSULE;ORAL 203775 ANDA Ingenus Pharmaceuticals NJ, LLC 52682-500 52682-500-01 100 CAPSULE in 1 BOTTLE (52682-500-01)

Summary for product number 001

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

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