Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021338
Company: THE MEDICINES CO
Company: THE MEDICINES CO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
IONSYS | FENTANYL HYDROCHLORIDE | EQ 40MCG BASE/ACTIVATION | SYSTEM;IONTOPHORESIS, TRANSDERMAL | 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 |
---|---|---|---|---|---|---|---|
05/22/2006 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021338lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021338s000_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021338_toc.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/03/2018 | SUPPL-10 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
03/29/2017 | SUPPL-9 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021338Orig1s009ltr.pdf |
12/16/2016 | SUPPL-7 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021338s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021338Orig1s007ltr.pdf | |
11/12/2015 | SUPPL-6 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021338Orig1s006ltr.pdf |
04/30/2015 | SUPPL-5 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021338s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021338Orig1s005ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/021338Orig1s005.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
12/16/2016 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021338s007lbl.pdf | |
04/30/2015 | SUPPL-5 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021338s005lbl.pdf | |
05/22/2006 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021338lbl.pdf |