Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 210660
Company: EXELA PHARMA
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 |