Application 021338
- Type
- NDA
- Sponsor
- THE MEDICINES CO
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | IONSYS | FENTANYL HYDROCHLORIDE | SYSTEM;IONTOPHORESIS, TRANSDERMAL | EQ 40MCG BASE/ACTIVATION | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021338-001 | IONSYS | FENTANYL HYDROCHLORIDE | EQ 40MCG BASE/ACTIVATION | SYSTEM / IONTOPHORESIS, TRANSDERMAL | RLD | 2006-05-22 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N021338-001 | 8301238 | 2031-09-30 | Drug product | ||
| N021338-001 | 9364656 | 2031-09-30 | U-736 | 2016-06-21 | |
| N021338-001 | 9731121 | 2031-10-17 | Drug product | 2017-09-12 | |
| N021338-001 | 8781571 | 2032-03-31 | U-736 | Drug product | 2015-05-28 |
| N021338-001 | 8428708 | 2032-05-21 | U-736 | ||
| N021338-001 | 8428709 | 2032-06-11 | U-736 | Drug product | 2015-05-28 |
| N021338-001 | 9095706 | 2033-02-03 | Drug product | 2015-08-06 |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N021338-001 | IONSYS | EQ 40MCG BASE/ACTIVATION | SYSTEM / IONTOPHORESIS, TRANSDERMAL | RLD | 2006-05-22 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N021338-001 | IONSYS | EQ 40MCG BASE/ACTIVATION | SYSTEM / IONTOPHORESIS, TRANSDERMAL | RLD | 2006-05-22 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021338-001 | IONSYS | EQ 40MCG BASE/ACTIVATION | SYSTEM / IONTOPHORESIS, TRANSDERMAL | RLD | 2006-05-22 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021338-001 | IONSYS | EQ 40MCG BASE/ACTIVATION | SYSTEM / IONTOPHORESIS, TRANSDERMAL | RLD | 2006-05-22 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021338-001 | IONSYS | EQ 40MCG BASE/ACTIVATION | SYSTEM / IONTOPHORESIS, TRANSDERMAL | RLD | 2006-05-22 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021338-001 | IONSYS | EQ 40MCG BASE/ACTIVATION | SYSTEM / IONTOPHORESIS, TRANSDERMAL | RLD | 2006-05-22 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021338-001 | IONSYS | EQ 40MCG BASE/ACTIVATION | SYSTEM / IONTOPHORESIS, TRANSDERMAL | RLD | 2006-05-22 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021338-001 | IONSYS | EQ 40MCG BASE/ACTIVATION | SYSTEM / IONTOPHORESIS, TRANSDERMAL | RLD | 2006-05-22 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021338-001 | IONSYS | EQ 40MCG BASE/ACTIVATION | SYSTEM / IONTOPHORESIS, TRANSDERMAL | RLD | 2006-05-22 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021338-001 | IONSYS | EQ 40MCG BASE/ACTIVATION | SYSTEM / IONTOPHORESIS, TRANSDERMAL | RLD | 2006-05-22 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021338-001 | IONSYS | EQ 40MCG BASE/ACTIVATION | SYSTEM / IONTOPHORESIS, TRANSDERMAL | RLD | 2006-05-22 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021338-001 | IONSYS | EQ 40MCG BASE/ACTIVATION | SYSTEM / IONTOPHORESIS, TRANSDERMAL | RLD | 2006-05-22 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021338-001 | IONSYS | EQ 40MCG BASE/ACTIVATION | SYSTEM / IONTOPHORESIS, TRANSDERMAL | RLD | 2006-05-22 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021338-001 | IONSYS | EQ 40MCG BASE/ACTIVATION | SYSTEM / IONTOPHORESIS, TRANSDERMAL | RLD | 2006-05-22 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021338-001 | IONSYS | EQ 40MCG BASE/ACTIVATION | SYSTEM / IONTOPHORESIS, TRANSDERMAL | RLD | 2006-05-22 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N021338-001 | IONSYS | EQ 40MCG BASE/ACTIVATION | SYSTEM / IONTOPHORESIS, TRANSDERMAL | RLD | 2006-05-22 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021338-001 | IONSYS | EQ 40MCG BASE/ACTIVATION | SYSTEM / IONTOPHORESIS, TRANSDERMAL | RLD | 2006-05-22 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N021338-001 | IONSYS | EQ 40MCG BASE/ACTIVATION | SYSTEM / IONTOPHORESIS, TRANSDERMAL | RLD | 2006-05-22 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N021338-001 | IONSYS | EQ 40MCG BASE/ACTIVATION | SYSTEM / IONTOPHORESIS, TRANSDERMAL | RLD | 2006-05-22 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021338-001 | IONSYS | EQ 40MCG BASE/ACTIVATION | SYSTEM / IONTOPHORESIS, TRANSDERMAL | RLD | 2006-05-22 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N021338-001 | IONSYS | EQ 40MCG BASE/ACTIVATION | SYSTEM / IONTOPHORESIS, TRANSDERMAL | RLD | 2006-05-22 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N021338-001 | IONSYS | EQ 40MCG BASE/ACTIVATION | SYSTEM / IONTOPHORESIS, TRANSDERMAL | RLD | 2006-05-22 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021338-001 | IONSYS | EQ 40MCG BASE/ACTIVATION | SYSTEM / IONTOPHORESIS, TRANSDERMAL | RLD | 2006-05-22 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N021338-001 | IONSYS | EQ 40MCG BASE/ACTIVATION | SYSTEM / IONTOPHORESIS, TRANSDERMAL | RLD | 2006-05-22 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N021338-001 | IONSYS | EQ 40MCG BASE/ACTIVATION | SYSTEM / IONTOPHORESIS, TRANSDERMAL | RLD | 2006-05-22 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N021338-001 | IONSYS | EQ 40MCG BASE/ACTIVATION | SYSTEM / IONTOPHORESIS, TRANSDERMAL | RLD | 2006-05-22 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N021338-001 | IONSYS | EQ 40MCG BASE/ACTIVATION | SYSTEM / IONTOPHORESIS, TRANSDERMAL | RLD | 2006-05-22 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N021338-001 | IONSYS | EQ 40MCG BASE/ACTIVATION | SYSTEM / IONTOPHORESIS, TRANSDERMAL | RLD | 2006-05-22 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N021338-001 | IONSYS | EQ 40MCG BASE/ACTIVATION | SYSTEM / IONTOPHORESIS, TRANSDERMAL | RLD | 2006-05-22 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N021338-001 | IONSYS | EQ 40MCG BASE/ACTIVATION | SYSTEM / IONTOPHORESIS, TRANSDERMAL | RLD | 2006-05-22 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N021338-001 | IONSYS | EQ 40MCG BASE/ACTIVATION | SYSTEM / IONTOPHORESIS, TRANSDERMAL | RLD | 2006-05-22 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N021338-001 | IONSYS | EQ 40MCG BASE/ACTIVATION | SYSTEM / IONTOPHORESIS, TRANSDERMAL | RLD | 2006-05-22 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N021338-001 | IONSYS | EQ 40MCG BASE/ACTIVATION | SYSTEM / IONTOPHORESIS, TRANSDERMAL | RLD | 2006-05-22 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N021338-001 | IONSYS | EQ 40MCG BASE/ACTIVATION | SYSTEM / IONTOPHORESIS, TRANSDERMAL | RLD | 2006-05-22 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N021338-001 | IONSYS | EQ 40MCG BASE/ACTIVATION | SYSTEM / IONTOPHORESIS, TRANSDERMAL | RLD | 2006-05-22 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N021338-001 | IONSYS | EQ 40MCG BASE/ACTIVATION | SYSTEM / IONTOPHORESIS, TRANSDERMAL | RLD | 2006-05-22 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N021338-001 | IONSYS | EQ 40MCG BASE/ACTIVATION | SYSTEM / IONTOPHORESIS, TRANSDERMAL | RLD | 2006-05-22 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N021338-001 | IONSYS | EQ 40MCG BASE/ACTIVATION | SYSTEM / IONTOPHORESIS, TRANSDERMAL | RLD | 2006-05-22 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N021338-001 | IONSYS | EQ 40MCG BASE/ACTIVATION | SYSTEM / IONTOPHORESIS, TRANSDERMAL | RLD | 2006-05-22 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N021338-001 | IONSYS | EQ 40MCG BASE/ACTIVATION | SYSTEM / IONTOPHORESIS, TRANSDERMAL | RLD | 2006-05-22 | f41ea6bd6efb… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N021338-001 | 8301238 | 2031-09-30 | Drug product | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N021338-001 | 9364656 | 2031-09-30 | U-736 | 2016-06-21 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021338-001 | 9731121 | 2031-10-17 | Drug product | 2017-09-12 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021338-001 | 8781571 | 2032-03-31 | U-736 | Drug product | 2015-05-28 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021338-001 | 8428708 | 2032-05-21 | U-736 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N021338-001 | 8428709 | 2032-06-11 | U-736 | Drug product | 2015-05-28 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021338-001 | 9095706 | 2033-02-03 | Drug product | 2015-08-06 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N021338-001 | 8301238 | 2031-09-30 | Drug product | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N021338-001 | 9364656 | 2031-09-30 | U-736 | 2016-06-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021338-001 | 9731121 | 2031-10-17 | Drug product | 2017-09-12 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021338-001 | 8781571 | 2032-03-31 | U-736 | Drug product | 2015-05-28 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021338-001 | 8428708 | 2032-05-21 | U-736 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N021338-001 | 8428709 | 2032-06-11 | U-736 | Drug product | 2015-05-28 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021338-001 | 9095706 | 2033-02-03 | Drug product | 2015-08-06 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021338-001 | 8301238 | 2031-09-30 | Drug product | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N021338-001 | 9364656 | 2031-09-30 | U-736 | 2016-06-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021338-001 | 9731121 | 2031-10-17 | Drug product | 2017-09-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021338-001 | 8781571 | 2032-03-31 | U-736 | Drug product | 2015-05-28 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021338-001 | 8428708 | 2032-05-21 | U-736 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N021338-001 | 8428709 | 2032-06-11 | U-736 | Drug product | 2015-05-28 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021338-001 | 9095706 | 2033-02-03 | Drug product | 2015-08-06 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021338-001 | 8301238 | 2031-09-30 | Drug product | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021338-001 | 9364656 | 2031-09-30 | U-736 | 2016-06-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021338-001 | 9731121 | 2031-10-17 | Drug product | 2017-09-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021338-001 | 8781571 | 2032-03-31 | U-736 | Drug product | 2015-05-28 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021338-001 | 8428708 | 2032-05-21 | U-736 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021338-001 | 8428709 | 2032-06-11 | U-736 | Drug product | 2015-05-28 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021338-001 | 9095706 | 2033-02-03 | Drug product | 2015-08-06 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021338-001 | 8301238 | 2031-09-30 | Drug product | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N021338-001 | 9364656 | 2031-09-30 | U-736 | 2016-06-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021338-001 | 9731121 | 2031-10-17 | Drug product | 2017-09-12 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021338-001 | 8781571 | 2032-03-31 | U-736 | Drug product | 2015-05-28 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021338-001 | 8428708 | 2032-05-21 | U-736 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N021338-001 | 8428709 | 2032-06-11 | U-736 | Drug product | 2015-05-28 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021338-001 | 9095706 | 2033-02-03 | Drug product | 2015-08-06 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021338-001 | 8301238 | 2031-09-30 | Drug product | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021338-001 | 9364656 | 2031-09-30 | U-736 | 2016-06-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021338-001 | 9731121 | 2031-10-17 | Drug product | 2017-09-12 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021338-001 | 8781571 | 2032-03-31 | U-736 | Drug product | 2015-05-28 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021338-001 | 8428708 | 2032-05-21 | U-736 | fd3edfee7708… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 65293-011 | IONSYS | fentanyl iontophoretic transdermal system | The Medicines Company | NDA | Current |