Application 022569
- Type
- NDA
- Sponsor
- BTCP PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LAZANDA | FENTANYL CITRATE | SPRAY, METERED;NASAL | EQ 0.1MG BASE | Yes | No |
| 002 | LAZANDA | FENTANYL CITRATE | SPRAY, METERED;NASAL | EQ 0.4MG BASE | Yes | Yes |
| 003 | LAZANDA | FENTANYL CITRATE | SPRAY, METERED;NASAL | EQ 0.3MG BASE | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 13913-009 | Lazanda | fentanyl citrate | Depomed, Inc. | NDA | Current |
| 13913-010 | Lazanda | fentanyl citrate | Depomed, Inc. | NDA | Current |
| 13913-013 | Lazanda | fentanyl citrate | Depomed, Inc. | NDA | Current |
| 51772-311 | LAZANDA | Fentanyl Citrate | Archimedes Pharma US Inc. | NDA | Current |
| 51772-314 | LAZANDA | Fentanyl Citrate | Archimedes Pharma US Inc. | NDA | Current |
| 71500-110 | LAZANDA | fentanyl | West Therapeutic Development LLC | NDA | Current |
| 71500-110 | LAZANDA | fentanyl | West Therapeutic Development LLC | NDA | Current |
| 71500-110 | Lazanda | fentanyl | West Therapeutic Development LLC | NDA | Current |
| 71500-110 | Lazanda | fentanyl | West Therapeutic Development LLC | NDA | Current |
| 71500-130 | Lazanda | fentanyl | West Therapeutic Development LLC | NDA | Current |
| 71500-130 | Lazanda | fentanyl | West Therapeutic Development LLC | NDA | Current |
| 71500-130 | LAZANDA | fentanyl | West Therapeutic Development LLC | NDA | Current |
| 71500-130 | LAZANDA | fentanyl | West Therapeutic Development LLC | NDA | Current |
| 71500-140 | Lazanda | fentanyl | West Therapeutic Development LLC | NDA | Current |
| 71500-140 | Lazanda | fentanyl | West Therapeutic Development LLC | NDA | Current |
| 71500-140 | LAZANDA | fentanyl | West Therapeutic Development LLC | NDA | Current |
| 71500-140 | LAZANDA | fentanyl | West Therapeutic Development LLC | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 72849 | SUPPL | 2022-12-09 |
| 71842 | SUPPL | 2022-08-18 |
| 69496 | SUPPL | 2021-12-07 |
| 66625 | SUPPL | 2021-03-08 |
| 66624 | SUPPL | 2021-03-08 |
| 66567 | SUPPL | 2021-03-08 |
| 65767 | SUPPL | 2020-12-28 |
| 60496 | SUPPL | 2019-10-09 |
| 60495 | SUPPL | 2019-10-09 |
| 60447 | SUPPL | 2019-10-09 |
| 49715 | SUPPL | 2017-09-11 |
| 47684 | SUPPL | 2017-03-24 |
| 47634 | SUPPL | 2017-03-22 |
| 47633 | SUPPL | 2017-03-22 |
| 46382 | SUPPL | 2016-12-21 |
| 46330 | SUPPL | 2016-12-21 |
| 29870 | SUPPL | 2015-12-22 |
| 38852 | SUPPL | 2015-01-09 |
| 38851 | SUPPL | 2015-01-08 |
| 38850 | SUPPL | 2015-01-08 |
| 29869 | SUPPL | 2014-12-31 |
| 29868 | SUPPL | 2014-12-31 |
| 7552 | SUPPL | 2014-12-31 |
| 17723 | SUPPL | 2013-11-19 |
| 17722 | SUPPL | 2013-11-19 |
| 17721 | SUPPL | 2013-11-19 |
| 7551 | SUPPL | 2013-11-13 |
| 7550 | SUPPL | 2013-11-13 |
| 7549 | SUPPL | 2013-11-13 |
| 38849 | SUPPL | 2012-06-11 |
| 7548 | SUPPL | 2012-06-07 |
| 44779 | ORIG | 2012-04-16 |
| 42560 | ORIG | 2012-04-16 |
| 7547 | SUPPL | 2012-01-03 |
| 38848 | SUPPL | 2011-12-28 |
| 7546 | SUPPL | 2011-11-14 |
| 44511 | ORIG | 2011-07-08 |
| 17720 | ORIG | 2011-07-06 |
| 7545 | ORIG | 2011-07-06 |