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Last Updated: June 24, 2021

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Details for New Drug Application (NDA): 017871


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NDA 017871 describes DEMSER, which is a drug marketed by Bausch and is included in one NDA. It is available from two suppliers. Additional details are available on the DEMSER profile page.

The generic ingredient in DEMSER is metyrosine. There are two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the metyrosine profile page.
Summary for 017871
Tradename:DEMSER
Applicant:Bausch
Ingredient:metyrosine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 017871
Suppliers and Packaging for NDA: 017871
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEMSER metyrosine CAPSULE;ORAL 017871 NDA Bausch Health US, LLC 25010-305 25010-305-15 100 CAPSULE in 1 BOTTLE (25010-305-15)
DEMSER metyrosine CAPSULE;ORAL 017871 NDA AUTHORIZED GENERIC Oceanside Pharmaceuticals 68682-310 68682-310-01 100 CAPSULE in 1 BOTTLE (68682-310-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength250MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

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