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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 210660
Company: EXELA PHARMA

Products on NDA 210660

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ELCYS	CYSTEINE HYDROCHLORIDE	500MG/10ML (50MG/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	Yes	Yes
ELCYS	CYSTEINE HYDROCHLORIDE	2500MG/50ML (50MG/ML)	SOLUTION;INTRAVENOUS	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 210660

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/16/2019	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210660lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210660Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/210660Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/04/2023	SUPPL-5	Manufacturing (CMC)-New Strength	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210660Orig1s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/210660Orig1s005ltr.pdf

Labels for NDA 210660

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/04/2023	SUPPL-5	Manufacturing (CMC)-New Strength	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210660Orig1s005lbl.pdf
04/16/2019	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210660lbl.pdf

Therapeutic Equivalents for NDA 210660

ELCYS

SOLUTION;INTRAVENOUS; 500MG/10ML (50MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ELCYS	CYSTEINE HYDROCHLORIDE	500MG/10ML (50MG/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	210660	EXELA PHARMA

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