FDA.reportPublic FDA data

Application 021338

Type
NDA
Sponsor
THE MEDICINES CO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IONSYSFENTANYL HYDROCHLORIDESYSTEM;IONTOPHORESIS, TRANSDERMALEQ 40MCG BASE/ACTIVATIONYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
65293-011IONSYSfentanyl iontophoretic transdermal systemThe Medicines CompanyNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
57401SUPPL2019-02-01
47829SUPPL2017-04-03
46355SUPPL2016-12-21
46282SUPPL2016-12-20
27516SUPPL2015-11-16
23996ORIG2015-07-02
15218SUPPL2015-05-06
5083SUPPL2015-05-04
42108ORIG2008-01-16
5082ORIG2008-01-16
15217ORIG2006-05-24