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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021338-001IONSYSFENTANYL HYDROCHLORIDEEQ 40MCG BASE/ACTIVATIONSYSTEM / IONTOPHORESIS, TRANSDERMALRLD2006-05-22

Orange Book patents#

Current patent rows page 1 of 1 · 7 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N021338-00183012382031-09-30Drug product
N021338-00193646562031-09-30U-7362016-06-21
N021338-00197311212031-10-17Drug product2017-09-12
N021338-00187815712032-03-31U-736Drug product2015-05-28
N021338-00184287082032-05-21U-736
N021338-00184287092032-06-11U-736Drug product2015-05-28
N021338-00190957062033-02-03Drug product2015-08-06

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N021338-001IONSYSEQ 40MCG BASE/ACTIVATIONSYSTEM / IONTOPHORESIS, TRANSDERMALRLD2006-05-22f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021338-001IONSYSEQ 40MCG BASE/ACTIVATIONSYSTEM / IONTOPHORESIS, TRANSDERMALRLD2006-05-22e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021338-001IONSYSEQ 40MCG BASE/ACTIVATIONSYSTEM / IONTOPHORESIS, TRANSDERMALRLD2006-05-22cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N021338-001IONSYSEQ 40MCG BASE/ACTIVATIONSYSTEM / IONTOPHORESIS, TRANSDERMALRLD2006-05-22a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 10 · 369 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-10-15 13:18:302026-09N021338-00183012382031-09-30Drug productc2088c7a36db…
2026-10-15 13:18:302026-09N021338-00193646562031-09-30U-7362016-06-21c2088c7a36db…
2026-10-15 13:18:302026-09N021338-00197311212031-10-17Drug product2017-09-12c2088c7a36db…
2026-10-15 13:18:302026-09N021338-00187815712032-03-31U-736Drug product2015-05-28c2088c7a36db…
2026-10-15 13:18:302026-09N021338-00184287082032-05-21U-736c2088c7a36db…
2026-10-15 13:18:302026-09N021338-00184287092032-06-11U-736Drug product2015-05-28c2088c7a36db…
2026-10-15 13:18:302026-09N021338-00190957062033-02-03Drug product2015-08-06c2088c7a36db…
2026-09-14 22:38:342026-08N021338-00183012382031-09-30Drug product84e616aacf4f…
2026-09-14 22:38:342026-08N021338-00193646562031-09-30U-7362016-06-2184e616aacf4f…
2026-09-14 22:38:342026-08N021338-00197311212031-10-17Drug product2017-09-1284e616aacf4f…
2026-09-14 22:38:342026-08N021338-00187815712032-03-31U-736Drug product2015-05-2884e616aacf4f…
2026-09-14 22:38:342026-08N021338-00184287082032-05-21U-73684e616aacf4f…
2026-09-14 22:38:342026-08N021338-00184287092032-06-11U-736Drug product2015-05-2884e616aacf4f…
2026-09-14 22:38:342026-08N021338-00190957062033-02-03Drug product2015-08-0684e616aacf4f…
2026-08-18 06:07:402026-07N021338-00183012382031-09-30Drug productcaaa826d4ba7…
2026-08-18 06:07:402026-07N021338-00193646562031-09-30U-7362016-06-21caaa826d4ba7…
2026-08-18 06:07:402026-07N021338-00197311212031-10-17Drug product2017-09-12caaa826d4ba7…
2026-08-18 06:07:402026-07N021338-00187815712032-03-31U-736Drug product2015-05-28caaa826d4ba7…
2026-08-18 06:07:402026-07N021338-00184287082032-05-21U-736caaa826d4ba7…
2026-08-18 06:07:402026-07N021338-00184287092032-06-11U-736Drug product2015-05-28caaa826d4ba7…
2026-08-18 06:07:402026-07N021338-00190957062033-02-03Drug product2015-08-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021338-00183012382031-09-30Drug product011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021338-00193646562031-09-30U-7362016-06-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021338-00197311212031-10-17Drug product2017-09-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021338-00187815712032-03-31U-736Drug product2015-05-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021338-00184287082032-05-21U-736011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021338-00184287092032-06-11U-736Drug product2015-05-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021338-00190957062033-02-03Drug product2015-08-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021338-00183012382031-09-30Drug product31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021338-00193646562031-09-30U-7362016-06-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021338-00197311212031-10-17Drug product2017-09-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021338-00187815712032-03-31U-736Drug product2015-05-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021338-00184287082032-05-21U-73631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021338-00184287092032-06-11U-736Drug product2015-05-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021338-00190957062033-02-03Drug product2015-08-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08N021338-00183012382031-09-30Drug product6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021338-00193646562031-09-30U-7362016-06-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021338-00197311212031-10-17Drug product2017-09-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021338-00187815712032-03-31U-736Drug product2015-05-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021338-00184287082032-05-21U-7366a471c1ec25d…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 1 matching rows.

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