Application 022549
- Type
- NDA
- Sponsor
- ALEXZA PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ADASUVE | LOXAPINE | POWDER;INHALATION | 10MG | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 10885-003 | Adasuve | loxapine | Galen US Incorporated | NDA | Current |
| 10885-003 | Adasuve | loxapine | Galen US Incorporated | NDA | Current |
| 51097-001 | Adasuve | loxapine | Alexza Pharmaceuticals, Inc. | NDA | Current |
| 57844-510 | Adasuve | loxapine | Teva Select Brands | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 76422 | ORIG | 2023-11-06 |
| 70027 | SUPPL | 2022-02-01 |
| 70011 | SUPPL | 2022-01-31 |
| 69996 | SUPPL | 2022-01-31 |
| 69171 | SUPPL | 2021-10-29 |
| 69169 | SUPPL | 2021-10-29 |
| 69147 | SUPPL | 2021-10-28 |
| 56224 | SUPPL | 2018-11-01 |
| 47372 | SUPPL | 2017-03-02 |
| 47350 | SUPPL | 2017-02-27 |
| 47286 | SUPPL | 2017-02-22 |
| 45491 | SUPPL | 2016-09-30 |
| 7526 | SUPPL | 2013-12-13 |
| 53677 | ORIG | 2013-08-09 |
| 53676 | ORIG | 2013-08-09 |
| 53675 | ORIG | 2013-08-09 |
| 53673 | ORIG | 2013-01-11 |
| 53674 | ORIG | 2012-12-27 |