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Generated: April 27, 2017

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Details for New Drug Application (NDA): 205494

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NDA 205494 describes CERDELGA, which is a drug marketed by Genzyme Corp and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the CERDELGA profile page.

The generic ingredient in CERDELGA is eliglustat tartrate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the eliglustat tartrate profile page.

Summary for NDA: 205494


Suppliers and Packaging for NDA: 205494

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
eliglustat tartrate
CAPSULE;ORAL 205494 NDA Genzyme Corporation 58468-0220 58468-0220-1 4 BLISTER PACK in 1 CARTON (58468-0220-1) > 14 CAPSULE in 1 BLISTER PACK
eliglustat tartrate
CAPSULE;ORAL 205494 NDA Genzyme Corporation 58468-0220 58468-0220-2 1 BLISTER PACK in 1 CARTON (58468-0220-2) > 14 CAPSULE in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 84MG BASE
Approval Date:Aug 19, 2014TE:RLD:Yes
Patent:7,196,205Patent Expiration:Apr 29, 2022Product Flag?Substance Flag?YDelist Request?
Regulatory Exclusivity Expiration:Aug 19, 2019
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Aug 19, 2021
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY

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