Application 202788
- Type
- NDA
- Sponsor
- BTCP PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SUBSYS | FENTANYL | SPRAY;SUBLINGUAL | 0.1MG | Yes | No |
| 002 | SUBSYS | FENTANYL | SPRAY;SUBLINGUAL | 0.2MG | Yes | No |
| 003 | SUBSYS | FENTANYL | SPRAY;SUBLINGUAL | 0.4MG | Yes | Yes |
| 004 | SUBSYS | FENTANYL | SPRAY;SUBLINGUAL | 0.6MG | Yes | No |
| 005 | SUBSYS | FENTANYL | SPRAY;SUBLINGUAL | 0.8MG | Yes | No |
| 006 | SUBSYS | FENTANYL | SPRAY;SUBLINGUAL | 1.2MG | Yes | No |
| 007 | SUBSYS | FENTANYL | SPRAY;SUBLINGUAL | 1.6MG | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N202788-001 | SUBSYS | FENTANYL | 0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | |
| N202788-002 | SUBSYS | FENTANYL | 0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | |
| N202788-003 | SUBSYS | FENTANYL | 0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | |
| N202788-004 | SUBSYS | FENTANYL | 0.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | |
| N202788-005 | SUBSYS | FENTANYL | 0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | |
| N202788-006 | SUBSYS | FENTANYL | 1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-08-30 | |
| N202788-007 | SUBSYS | FENTANYL | 1.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-08-30 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N202788-001 | 10016403 | 2027-01-25 | Drug product | 2018-08-10 | |
| N202788-001 | 10610523 | 2027-01-25 | Drug product | 2020-04-22 | |
| N202788-001 | 8835459 | 2027-01-25 | Drug product | 2014-09-24 | |
| N202788-001 | 8835460 | 2027-01-25 | U-55 | Drug product | 2014-09-24 |
| N202788-001 | 9241935 | 2027-01-25 | Drug product | 2016-02-18 | |
| N202788-001 | 9289387 | 2027-01-25 | U-55 | Drug product | 2017-05-15 |
| N202788-001 | 9642797 | 2027-01-25 | U-55 | Drug product | 2017-05-15 |
| N202788-001 | 9642844 | 2027-01-25 | Drug product | 2017-05-15 | |
| N202788-001 | 8486972 | 2030-04-27 | Drug product | 2013-07-30 | |
| N202788-001 | 8486973 | 2030-04-27 | U-55 | 2013-07-30 | |
| N202788-002 | 10016403 | 2027-01-25 | Drug product | 2018-08-10 | |
| N202788-002 | 10610523 | 2027-01-25 | Drug product | 2020-04-22 | |
| N202788-002 | 8835460 | 2027-01-25 | U-55 | Drug product | 2014-09-29 |
| N202788-002 | 9241935 | 2027-01-25 | Drug product | 2016-02-18 | |
| N202788-002 | 9289387 | 2027-01-25 | U-55 | Drug product | 2017-05-15 |
| N202788-002 | 9642797 | 2027-01-25 | U-55 | Drug product | 2017-05-15 |
| N202788-002 | 9642844 | 2027-01-25 | Drug product | 2017-05-15 | |
| N202788-002 | 8486972 | 2030-04-27 | Drug product | 2013-07-30 | |
| N202788-002 | 8486973 | 2030-04-27 | U-55 | 2013-07-30 | |
| N202788-003 | 10016403 | 2027-01-25 | Drug product | 2018-08-10 | |
| N202788-003 | 10610523 | 2027-01-25 | Drug product | 2020-04-22 | |
| N202788-003 | 8835459 | 2027-01-25 | Drug product | 2014-09-24 | |
| N202788-003 | 8835460 | 2027-01-25 | U-55 | Drug product | 2014-09-24 |
| N202788-003 | 9241935 | 2027-01-25 | Drug product | 2016-02-18 | |
| N202788-003 | 9289387 | 2027-01-25 | U-55 | Drug product | 2017-05-15 |
| N202788-003 | 9642797 | 2027-01-25 | U-55 | Drug product | 2017-05-15 |
| N202788-003 | 9642844 | 2027-01-25 | Drug product | 2017-05-15 | |
| N202788-003 | 8486972 | 2030-04-27 | Drug product | 2013-07-30 | |
| N202788-003 | 8486973 | 2030-04-27 | U-55 | 2013-07-30 | |
| N202788-004 | 10016403 | 2027-01-25 | Drug product | 2018-08-10 | |
| N202788-004 | 10610523 | 2027-01-25 | Drug product | 2020-04-22 | |
| N202788-004 | 8835459 | 2027-01-25 | Drug product | 2014-09-24 | |
| N202788-004 | 8835460 | 2027-01-25 | U-55 | Drug product | 2014-09-24 |
| N202788-004 | 9241935 | 2027-01-25 | Drug product | 2016-02-18 | |
| N202788-004 | 9289387 | 2027-01-25 | U-55 | Drug product | 2017-05-15 |
| N202788-004 | 9642797 | 2027-01-25 | U-55 | Drug product | 2017-05-15 |
| N202788-004 | 9642844 | 2027-01-25 | Drug product | 2017-05-15 | |
| N202788-004 | 8486972 | 2030-04-27 | Drug product | 2013-07-30 | |
| N202788-004 | 8486973 | 2030-04-27 | U-55 | 2013-07-30 | |
| N202788-005 | 10016403 | 2027-01-25 | Drug product | 2018-08-10 | |
| N202788-005 | 10610523 | 2027-01-25 | Drug product | 2020-04-22 | |
| N202788-005 | 8835460 | 2027-01-25 | U-55 | Drug product | 2014-09-24 |
| N202788-005 | 9241935 | 2027-01-25 | Drug product | 2016-02-18 | |
| N202788-005 | 9289387 | 2027-01-25 | U-55 | Drug product | 2017-05-15 |
| N202788-005 | 9642797 | 2027-01-25 | U-55 | Drug product | 2017-05-15 |
| N202788-005 | 9642844 | 2027-01-25 | Drug product | 2017-05-15 | |
| N202788-005 | 8486972 | 2030-04-27 | Drug product | 2013-07-30 | |
| N202788-005 | 8486973 | 2030-04-27 | U-55 | 2013-07-30 | |
| N202788-006 | 10016403 | 2027-01-25 | Drug product | 2018-08-10 | |
| N202788-006 | 10610523 | 2027-01-25 | Drug product | 2020-05-06 | |
| N202788-006 | 8835459 | 2027-01-25 | Drug product | 2014-09-24 | |
| N202788-006 | 8835460 | 2027-01-25 | U-55 | Drug product | 2014-09-24 |
| N202788-006 | 9241935 | 2027-01-25 | Drug product | 2016-02-18 | |
| N202788-006 | 9289387 | 2027-01-25 | U-55 | Drug product | 2017-05-15 |
| N202788-006 | 9642797 | 2027-01-25 | U-55 | Drug product | 2017-05-15 |
| N202788-006 | 9642844 | 2027-01-25 | Drug product | 2017-05-15 | |
| N202788-006 | 8486972 | 2030-04-27 | Drug product | 2013-07-30 | |
| N202788-006 | 8486973 | 2030-04-27 | U-55 | 2013-07-30 | |
| N202788-007 | 10016403 | 2027-01-25 | Drug product | 2018-08-10 | |
| N202788-007 | 10610523 | 2027-01-25 | Drug product | 2020-05-06 | |
| N202788-007 | 8835459 | 2027-01-25 | Drug product | 2014-09-24 | |
| N202788-007 | 8835460 | 2027-01-25 | U-55 | Drug product | 2014-09-29 |
| N202788-007 | 9241935 | 2027-01-25 | Drug product | 2016-02-18 | |
| N202788-007 | 9289387 | 2027-01-25 | U-55 | Drug product | 2017-05-15 |
| N202788-007 | 9642797 | 2027-01-25 | U-55 | Drug product | 2017-05-15 |
| N202788-007 | 9642844 | 2027-01-25 | Drug product | 2017-05-15 | |
| N202788-007 | 8486972 | 2030-04-27 | Drug product | 2013-07-30 | |
| N202788-007 | 8486973 | 2030-04-27 | U-55 | 2013-07-30 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N202788-001 | SUBSYS | 0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-002 | SUBSYS | 0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-003 | SUBSYS | 0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-004 | SUBSYS | 0.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-005 | SUBSYS | 0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-006 | SUBSYS | 1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-08-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-007 | SUBSYS | 1.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-08-30 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202788-001 | SUBSYS | 0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202788-002 | SUBSYS | 0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202788-003 | SUBSYS | 0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202788-004 | SUBSYS | 0.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202788-005 | SUBSYS | 0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202788-006 | SUBSYS | 1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-08-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202788-007 | SUBSYS | 1.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-08-30 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N202788-001 | SUBSYS | 0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N202788-002 | SUBSYS | 0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N202788-003 | SUBSYS | 0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N202788-004 | SUBSYS | 0.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N202788-005 | SUBSYS | 0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N202788-006 | SUBSYS | 1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-08-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N202788-007 | SUBSYS | 1.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-08-30 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202788-001 | SUBSYS | 0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202788-002 | SUBSYS | 0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202788-003 | SUBSYS | 0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202788-004 | SUBSYS | 0.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202788-005 | SUBSYS | 0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202788-006 | SUBSYS | 1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-08-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202788-007 | SUBSYS | 1.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-08-30 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202788-001 | SUBSYS | 0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202788-002 | SUBSYS | 0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202788-003 | SUBSYS | 0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202788-004 | SUBSYS | 0.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202788-005 | SUBSYS | 0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202788-006 | SUBSYS | 1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-08-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202788-007 | SUBSYS | 1.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-08-30 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202788-001 | SUBSYS | 0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202788-002 | SUBSYS | 0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202788-003 | SUBSYS | 0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202788-004 | SUBSYS | 0.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202788-005 | SUBSYS | 0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY / SUBLINGUAL | RLD | 2012-01-04 | 03ed91905a0d… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N202788-001 | 10016403 | 2027-01-25 | Drug product | 2018-08-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-001 | 10610523 | 2027-01-25 | Drug product | 2020-04-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-001 | 8835459 | 2027-01-25 | Drug product | 2014-09-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-001 | 8835460 | 2027-01-25 | U-55 | Drug product | 2014-09-24 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-001 | 9241935 | 2027-01-25 | Drug product | 2016-02-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-001 | 9289387 | 2027-01-25 | U-55 | Drug product | 2017-05-15 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-001 | 9642797 | 2027-01-25 | U-55 | Drug product | 2017-05-15 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-001 | 9642844 | 2027-01-25 | Drug product | 2017-05-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-001 | 8486972 | 2030-04-27 | Drug product | 2013-07-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-001 | 8486973 | 2030-04-27 | U-55 | 2013-07-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-002 | 10016403 | 2027-01-25 | Drug product | 2018-08-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-002 | 10610523 | 2027-01-25 | Drug product | 2020-04-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-002 | 8835460 | 2027-01-25 | U-55 | Drug product | 2014-09-29 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-002 | 9241935 | 2027-01-25 | Drug product | 2016-02-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-002 | 9289387 | 2027-01-25 | U-55 | Drug product | 2017-05-15 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-002 | 9642797 | 2027-01-25 | U-55 | Drug product | 2017-05-15 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-002 | 9642844 | 2027-01-25 | Drug product | 2017-05-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-002 | 8486972 | 2030-04-27 | Drug product | 2013-07-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-002 | 8486973 | 2030-04-27 | U-55 | 2013-07-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-003 | 10016403 | 2027-01-25 | Drug product | 2018-08-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-003 | 10610523 | 2027-01-25 | Drug product | 2020-04-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-003 | 8835459 | 2027-01-25 | Drug product | 2014-09-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-003 | 8835460 | 2027-01-25 | U-55 | Drug product | 2014-09-24 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-003 | 9241935 | 2027-01-25 | Drug product | 2016-02-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-003 | 9289387 | 2027-01-25 | U-55 | Drug product | 2017-05-15 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-003 | 9642797 | 2027-01-25 | U-55 | Drug product | 2017-05-15 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-003 | 9642844 | 2027-01-25 | Drug product | 2017-05-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-003 | 8486972 | 2030-04-27 | Drug product | 2013-07-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-003 | 8486973 | 2030-04-27 | U-55 | 2013-07-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-004 | 10016403 | 2027-01-25 | Drug product | 2018-08-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-004 | 10610523 | 2027-01-25 | Drug product | 2020-04-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-004 | 8835459 | 2027-01-25 | Drug product | 2014-09-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-004 | 8835460 | 2027-01-25 | U-55 | Drug product | 2014-09-24 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-004 | 9241935 | 2027-01-25 | Drug product | 2016-02-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-004 | 9289387 | 2027-01-25 | U-55 | Drug product | 2017-05-15 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-004 | 9642797 | 2027-01-25 | U-55 | Drug product | 2017-05-15 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-004 | 9642844 | 2027-01-25 | Drug product | 2017-05-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-004 | 8486972 | 2030-04-27 | Drug product | 2013-07-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-004 | 8486973 | 2030-04-27 | U-55 | 2013-07-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202788-005 | 10016403 | 2027-01-25 | Drug product | 2018-08-10 | 011fe1cb6892… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| FENTANYL | FENTANYL | Aveva Drug Delivery Systems Inc. | 73897c38-e4ec-40bc-9f41-3359ee23a5a8 | 2026-04-07 | Boxed warning, Warnings, Adverse reactions | FENTANYL |
| FENTANYL | FENTANYL | INGENUS PHARMACEUTICALS, LLC | bf02ffd0-cc5d-446b-b648-378f6885052f | 2026-04-07 | Boxed warning, Warnings, Adverse reactions | FENTANYL |
| Fentanyl system | FENTANYL | ALVOGEN | 242759ef-cb6d-4e3e-9f8d-5e31efa1f289 | 2026-03-02 | Boxed warning, Warnings, Adverse reactions | FENTANYL |
| FENTANYL | FENTANYL | Mylan Pharmaceuticals Inc. | 2a2238e9-4b5d-c56d-8663-dd354ff9ae0c | 2025-12-15 | Boxed warning, Warnings, Adverse reactions | FENTANYL |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 20482-001 | SUBSYS | fentanyl | Insys Therapeutics, Inc. | NDA | Current |
| 20482-001 | SUBSYS | fentanyl | Insys Therapeutics, Inc. | NDA | Current |
| 20482-001 | SUBSYS | fentanyl | Insys Therapeutics, Inc. | NDA | Current |
| 20482-001 | SUBSYS | fentanyl | Insys Therapeutics, Inc. | NDA | Current |
| 20482-001 | SUBSYS | fentanyl | Insys Therapeutics, Inc. | NDA | Current |
| 20482-002 | SUBSYS | fentanyl | Insys Therapeutics, Inc. | NDA | Current |
| 20482-002 | SUBSYS | fentanyl | Insys Therapeutics, Inc. | NDA | Current |
| 20482-002 | SUBSYS | fentanyl | Insys Therapeutics, Inc. | NDA | Current |
| 20482-002 | SUBSYS | fentanyl | Insys Therapeutics, Inc. | NDA | Current |
| 20482-002 | SUBSYS | fentanyl | Insys Therapeutics, Inc. | NDA | Current |
| 20482-004 | SUBSYS | fentanyl | Insys Therapeutics, Inc. | NDA | Current |
| 20482-004 | SUBSYS | fentanyl | Insys Therapeutics, Inc. | NDA | Current |
| 20482-004 | SUBSYS | fentanyl | Insys Therapeutics, Inc. | NDA | Current |
| 20482-004 | SUBSYS | fentanyl | Insys Therapeutics, Inc. | NDA | Current |
| 20482-004 | SUBSYS | fentanyl | Insys Therapeutics, Inc. | NDA | Current |
| 20482-006 | SUBSYS | fentanyl | Insys Therapeutics, Inc. | NDA | Current |
| 20482-006 | SUBSYS | fentanyl | Insys Therapeutics, Inc. | NDA | Current |
| 20482-006 | SUBSYS | fentanyl | Insys Therapeutics, Inc. | NDA | Current |
| 20482-006 | SUBSYS | fentanyl | Insys Therapeutics, Inc. | NDA | Current |
| 20482-006 | SUBSYS | fentanyl | Insys Therapeutics, Inc. | NDA | Current |
| 20482-008 | SUBSYS | fentanyl | Insys Therapeutics, Inc. | NDA | Current |
| 20482-008 | SUBSYS | fentanyl | Insys Therapeutics, Inc. | NDA | Current |
| 20482-008 | SUBSYS | fentanyl | Insys Therapeutics, Inc. | NDA | Current |
| 20482-008 | SUBSYS | fentanyl | Insys Therapeutics, Inc. | NDA | Current |
| 20482-008 | SUBSYS | fentanyl | Insys Therapeutics, Inc. | NDA | Current |
| 20482-012 | SUBSYS | fentanyl | Insys Therapeutics, Inc. | NDA | Current |
| 20482-012 | SUBSYS | fentanyl | Insys Therapeutics, Inc. | NDA | Current |
| 20482-012 | SUBSYS | fentanyl | Insys Therapeutics, Inc. | NDA | Current |
| 20482-012 | SUBSYS | fentanyl | Insys Therapeutics, Inc. | NDA | Current |
| 20482-012 | SUBSYS | fentanyl | Insys Therapeutics, Inc. | NDA | Current |
| 20482-016 | SUBSYS | fentanyl | Insys Therapeutics, Inc. | NDA | Current |
| 20482-016 | SUBSYS | fentanyl | Insys Therapeutics, Inc. | NDA | Current |
| 20482-016 | SUBSYS | fentanyl | Insys Therapeutics, Inc. | NDA | Current |
| 20482-016 | SUBSYS | fentanyl | Insys Therapeutics, Inc. | NDA | Current |
| 20482-016 | SUBSYS | fentanyl | Insys Therapeutics, Inc. | NDA | Current |
| 71500-001 | SUBSYS | fentanyl | West Therapeutics Development, LLC | NDA | Current |
| 71500-001 | SUBSYS | fentanyl | West Therapeutics Development, LLC | NDA | Current |
| 71500-001 | SUBSYS | fentanyl | West Therapeutics Development, LLC | NDA | Current |
| 71500-002 | SUBSYS | fentanyl | West Therapeutics Development, LLC | NDA | Current |
| 71500-002 | SUBSYS | fentanyl | West Therapeutics Development, LLC | NDA | Current |
| 71500-002 | SUBSYS | fentanyl | West Therapeutics Development, LLC | NDA | Current |
| 71500-004 | SUBSYS | fentanyl | West Therapeutics Development, LLC | NDA | Current |
| 71500-004 | SUBSYS | fentanyl | West Therapeutics Development, LLC | NDA | Current |
| 71500-004 | SUBSYS | fentanyl | West Therapeutics Development, LLC | NDA | Current |
| 71500-006 | SUBSYS | fentanyl | West Therapeutics Development, LLC | NDA | Current |
| 71500-006 | SUBSYS | fentanyl | West Therapeutics Development, LLC | NDA | Current |
| 71500-006 | SUBSYS | fentanyl | West Therapeutics Development, LLC | NDA | Current |
| 71500-008 | SUBSYS | fentanyl | West Therapeutics Development, LLC | NDA | Current |
| 71500-008 | SUBSYS | fentanyl | West Therapeutics Development, LLC | NDA | Current |
| 71500-008 | SUBSYS | fentanyl | West Therapeutics Development, LLC | NDA | Current |
| 71500-012 | SUBSYS | fentanyl | West Therapeutics Development, LLC | NDA | Current |
| 71500-012 | SUBSYS | fentanyl | West Therapeutics Development, LLC | NDA | Current |
| 71500-012 | SUBSYS | fentanyl | West Therapeutics Development, LLC | NDA | Current |
| 71500-016 | SUBSYS | fentanyl | West Therapeutics Development, LLC | NDA | Current |
| 71500-016 | SUBSYS | fentanyl | West Therapeutics Development, LLC | NDA | Current |
| 71500-016 | SUBSYS | fentanyl | West Therapeutics Development, LLC | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 72850 | SUPPL | 2022-12-09 |
| 71843 | SUPPL | 2022-08-18 |
| 69499 | SUPPL | 2021-12-07 |
| 66643 | SUPPL | 2021-03-08 |
| 66642 | SUPPL | 2021-03-08 |
| 66577 | SUPPL | 2021-03-08 |
| 65763 | SUPPL | 2020-12-28 |
| 60500 | SUPPL | 2019-10-09 |
| 60499 | SUPPL | 2019-10-09 |
| 60454 | SUPPL | 2019-10-09 |
| 49716 | SUPPL | 2017-09-11 |
| 46597 | SUPPL | 2016-12-30 |
| 46429 | SUPPL | 2016-12-21 |
| 46302 | SUPPL | 2016-12-20 |
| 40218 | SUPPL | 2015-01-09 |
| 19377 | SUPPL | 2015-01-09 |
| 19376 | SUPPL | 2015-01-09 |
| 32303 | SUPPL | 2014-12-31 |
| 10109 | SUPPL | 2014-12-31 |
| 10107 | SUPPL | 2014-12-31 |
| 10108 | SUPPL | 2013-11-12 |
| 40217 | SUPPL | 2013-08-09 |
| 40216 | SUPPL | 2013-08-09 |
| 32302 | SUPPL | 2013-08-05 |
| 10106 | SUPPL | 2013-08-05 |
| 44865 | ORIG | 2012-09-06 |
| 22896 | ORIG | 2012-09-06 |
| 32300 | SUPPL | 2012-09-04 |
| 19375 | SUPPL | 2012-08-31 |
| 24105 | ORIG | 2012-06-15 |
| 40215 | SUPPL | 2012-06-11 |
| 40214 | SUPPL | 2012-06-11 |
| 32301 | SUPPL | 2012-06-07 |
| 32299 | SUPPL | 2012-06-07 |
| 24106 | ORIG | 2012-02-01 |
| 40213 | ORIG | 2012-01-06 |
| 32298 | ORIG | 2012-01-06 |