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Details for New Drug Application (NDA): 022458

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NDA 022458 describes ELELYSO, which is a drug marketed by Pfizer 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 ELELYSO profile page.

The generic ingredient in ELELYSO is taliglucerase alfa. One supplier is listed for this compound. Additional details are available on the taliglucerase alfa profile page.

Summary for NDA: 022458

Tradename:
ELELYSO
Applicant:
Pfizer
Ingredient:
taliglucerase alfa
Patents:3

Pharmacology for NDA: 022458

Ingredient-typeGlucosylceramidase

Suppliers and Packaging for NDA: 022458

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ELELYSO
taliglucerase alfa
POWDER;IV (INFUSION) 022458 NDA Pfizer Laboratories Div Pfizer Inc 0069-0106 0069-0106-01 1 VIAL, GLASS in 1 BOX (0069-0106-01) > 5 mL in 1 VIAL, GLASS

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;IV (INFUSION)Strength200 UNITS/VIAL
Approval Date:May 1, 2012TE:RLD:Yes
Patent:8,227,230Patent Expiration:Feb 24, 2024Product Flag?YSubstance Flag?YDelist Request?
Patent:8,741,620Patent Expiration:Feb 24, 2024Product Flag?YSubstance Flag?YDelist Request?
Patent:8,790,641Patent Expiration:Oct 18, 2025Product Flag?Substance Flag?Delist Request?
Patented Use:A METHOD OF CATALYZING THE HYDROLYSIS OF GLUCOCEREBROSIDE TO GLUCOSE AND CERAMIDE.


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