Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021338
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

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