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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 210660


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NDA 210660 describes ELCYS, which is a drug marketed by Exela Pharma and is included in one NDA. It is available from one supplier. There are sixteen patents protecting this drug. Additional details are available on the ELCYS profile page.

The generic ingredient in ELCYS is cysteine hydrochloride. There are fourteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the cysteine hydrochloride profile page.
Summary for 210660
Tradename:ELCYS
Applicant:Exela Pharma
Ingredient:cysteine hydrochloride
Patents:16
Suppliers and Packaging for NDA: 210660
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ELCYS cysteine hydrochloride SOLUTION;INTRAVENOUS 210660 NDA Exela Pharma Sciences, LLC 51754-1007 51754-1007-1 10 mL in 1 VIAL (51754-1007-1)
ELCYS cysteine hydrochloride SOLUTION;INTRAVENOUS 210660 NDA Exela Pharma Sciences, LLC 51754-1007 51754-1007-3 100 mL in 1 CARTON (51754-1007-3)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength500MG/10ML (50MG/ML)
Approval Date:Apr 16, 2019TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Jan 15, 2039Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF USING L-CYSTEINE IN AN ADMIXTURE FOR TREATING PATIENTS NEEDING PARENTERAL NUTRITION
Patent:⤷  Sign UpPatent Expiration:Jan 15, 2039Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF USING L-CYSTEINE IN AN ADMIXTURE FOR TREATING PATIENTS NEEDING PARENTERAL NUTRITION
Patent:⤷  Sign UpPatent Expiration:Jan 15, 2039Product Flag?YSubstance Flag?Delist Request?

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