Application 022266
- Type
- NDA
- Sponsor
- BDSI
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ONSOLIS | FENTANYL CITRATE | FILM;BUCCAL | EQ 0.2MG BASE | No | No |
| 002 | ONSOLIS | FENTANYL CITRATE | FILM;BUCCAL | EQ 0.4MG BASE | No | No |
| 003 | ONSOLIS | FENTANYL CITRATE | FILM;BUCCAL | EQ 0.6MG BASE | No | No |
| 004 | ONSOLIS | FENTANYL CITRATE | FILM;BUCCAL | EQ 0.8MG BASE | No | No |
| 005 | ONSOLIS | FENTANYL CITRATE | FILM;BUCCAL | EQ 1.2MG BASE | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 71841 | SUPPL | 2022-08-18 |
| 69495 | SUPPL | 2021-12-07 |
| 66605 | SUPPL | 2021-03-08 |
| 66604 | SUPPL | 2021-03-08 |
| 66557 | SUPPL | 2021-03-05 |
| 65766 | SUPPL | 2020-12-28 |
| 60492 | SUPPL | 2019-10-09 |
| 60491 | SUPPL | 2019-10-09 |
| 60441 | SUPPL | 2019-10-09 |
| 49713 | SUPPL | 2017-09-11 |
| 46345 | SUPPL | 2016-12-21 |
| 46344 | SUPPL | 2016-12-21 |
| 46298 | SUPPL | 2016-12-20 |
| 46297 | SUPPL | 2016-12-20 |
| 38469 | SUPPL | 2015-08-12 |
| 38468 | SUPPL | 2015-01-09 |
| 29497 | SUPPL | 2014-12-30 |
| 7136 | SUPPL | 2013-11-08 |
| 17171 | SUPPL | 2012-06-11 |
| 7135 | SUPPL | 2012-06-07 |
| 29496 | SUPPL | 2012-01-03 |
| 24020 | ORIG | 2011-12-30 |
| 38467 | SUPPL | 2011-12-28 |
| 44178 | ORIG | 2011-12-22 |
| 38466 | SUPPL | 2010-07-12 |
| 29495 | SUPPL | 2010-07-08 |
| 44721 | ORIG | 2009-11-05 |
| 42474 | ORIG | 2009-11-05 |
| 29494 | ORIG | 2009-07-17 |
| 24022 | ORIG | 2009-07-17 |
| 24021 | ORIG | 2009-07-17 |
| 17170 | ORIG | 2009-07-17 |