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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 209821


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NDA 209821 describes YARGESA, which is a drug marketed by Edenbridge Pharms and is included in one NDA. It is available from one supplier. Additional details are available on the YARGESA profile page.

The generic ingredient in YARGESA is miglustat. There are two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the miglustat profile page.
Summary for 209821
Tradename:YARGESA
Applicant:Edenbridge Pharms
Ingredient:miglustat
Patents:0
Pharmacology for NDA: 209821
Suppliers and Packaging for NDA: 209821
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
YARGESA miglustat CAPSULE;ORAL 209821 ANDA Edenbridge Pharmaceuticals LLC. 42799-709 42799-709-15 1 BLISTER PACK in 1 CARTON (42799-709-15) / 15 CAPSULE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Aug 6, 2020TE:ABRLD:No

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