Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 207793
Company: IPSEN
Company: IPSEN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ONIVYDE | IRINOTECAN HYDROCHLORIDE | EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML) | INJECTABLE, LIPOSOMAL;INTRAVENOUS | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
10/22/2015 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | PRIORITY; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207793lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207793Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207793Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/23/2024 | SUPPL-18 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/207793s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/207793Orig1s018ltr.pdf | |
02/13/2024 | SUPPL-16 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/207793s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/207793Orig1s016ltr.pdf | |
02/03/2023 | SUPPL-15 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/207793s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/207793Orig1s015ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
12/23/2024 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/207793s018lbl.pdf | |
02/13/2024 | SUPPL-16 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/207793s016lbl.pdf | |
02/03/2023 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/207793s015lbl.pdf | |
10/22/2015 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207793lbl.pdf |