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 |
| 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 |