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Last Updated: July 3, 2020

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Details for New Drug Application (NDA): 210660


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NDA 210660 describes ELCYS, which is a drug marketed by Exela Pharma Scs Llc and is included in one NDA. It is available from one supplier. There are two 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. One supplier is listed for this compound. Additional details are available on the cysteine hydrochloride profile page.
Summary for 210660
Tradename:ELCYS
Applicant:Exela Pharma Scs Llc
Ingredient:cysteine hydrochloride
Patents:2
Formulation / Manufacturing:see details
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)
Paragraph IV (Patent) Challenges for 210660
Tradename Dosage Ingredient NDA Submissiondate
ELCYS SOLUTION;INTRAVENOUS cysteine hydrochloride 210660 2019-12-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength500MG/10ML (50MG/ML)
Approval Date:Apr 16, 2019TE:RLD:Yes
Patent:  Start TrialPatent 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:  Start TrialPatent 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

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