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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021338
Company: THE MEDICINES CO

REMS

Products on NDA 021338

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021338

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

Labels for NDA 021338

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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