Details for New Drug Application (NDA): 210660

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:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	500MG/10ML (50MG/ML)
Approval Date:	Apr 16, 2019	TE:		RLD:	Yes
Patent:	10,478,453	Patent Expiration:	Jan 15, 2039	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	METHOD OF USING L-CYSTEINE IN AN ADMIXTURE FOR TREATING PATIENTS NEEDING PARENTERAL NUTRITION
Patent:	10,583,155	Patent Expiration:	Jan 15, 2039	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	METHOD OF USING L-CYSTEINE IN AN ADMIXTURE FOR TREATING PATIENTS NEEDING PARENTERAL NUTRITION
Patent:	10,653,719	Patent Expiration:	Jan 15, 2039	Product Flag?	Y	Substance Flag?		Delist Request?

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