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Drugs@FDA: FDA-Approved Drugs

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

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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