Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022549
Company: ALEXZA PHARMS
Company: ALEXZA PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ADASUVE | LOXAPINE | 10MG | POWDER;INHALATION | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/21/2012 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022549s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022549Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022549_adasuve_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022549Orig1s000SumR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022549Orig1s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/27/2022 | SUPPL-10 | Labeling-Patient Package Insert, REMS - MODIFIED - D-N-A |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022549s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022549Orig1s010ltr.pdf | |
| 10/27/2021 | SUPPL-9 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022549s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022549Orig1s009ltr.pdf | |
| 02/23/2017 | SUPPL-6 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022549s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022549Orig1s006ltr.pdf | |
| 09/28/2016 | SUPPL-5 | Labeling-Patient Package Insert, REMS-Modified |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022549s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022549Orig1s005ltr.pdf | |
| 12/09/2013 | SUPPL-2 | REMS-Assessment, REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022549Orig1s002ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/27/2022 | SUPPL-10 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022549s010lbl.pdf | |
| 01/27/2022 | SUPPL-10 | REMS - MODIFIED - D-N-A | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022549s010lbl.pdf | |
| 10/27/2021 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022549s009lbl.pdf | |
| 02/23/2017 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022549s006lbl.pdf | |
| 09/28/2016 | SUPPL-5 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022549s005lbl.pdf | |
| 09/28/2016 | SUPPL-5 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022549s005lbl.pdf | |
| 12/21/2012 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022549s000lbl.pdf |