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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 213734


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NDA 213734 describes METYROSINE, which is a drug marketed by Amneal and is included in one NDA. It is available from one supplier. Additional details are available on the METYROSINE profile page.

The generic ingredient in METYROSINE 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 213734
Tradename:METYROSINE
Applicant:Amneal
Ingredient:metyrosine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 213734
Suppliers and Packaging for NDA: 213734
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METYROSINE metyrosine CAPSULE;ORAL 213734 ANDA Amneal Pharmaceuticals NY LLC 69238-1621 69238-1621-1 100 CAPSULE in 1 BOTTLE, PLASTIC (69238-1621-1)
METYROSINE metyrosine CAPSULE;ORAL 213734 ANDA Amneal Pharmaceuticals NY LLC 69238-1621 69238-1621-3 30 CAPSULE in 1 BOTTLE, PLASTIC (69238-1621-3)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength250MG
Approval Date:Jul 24, 2020TE:ABRLD:No

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