Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 202450
Company: COVIS
Company: COVIS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TUDORZA PRESSAIR | ACLIDINIUM BROMIDE | 0.4MG/INH | POWDER, METERED;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 |
---|---|---|---|---|---|---|---|
07/23/2012 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202450s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202450Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202450Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202450Orig1s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/29/2019 | SUPPL-12 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202450s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/202450Orig1s012ltr.pdf | |
11/09/2018 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202450s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202450Orig1s011ltr.pdf | |
03/24/2016 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/16/2016 | SUPPL-6 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202450s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202450Orig1s006ltr.pdf | |
04/03/2015 | SUPPL-5 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202450s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202450Orig1s005ltr.pdf | |
10/23/2014 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/30/2014 | SUPPL-3 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202450Orig1s003ltr.pdf |
07/17/2014 | SUPPL-2 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202450s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202450Orig1s002ltr.pdf | |
05/03/2013 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
03/29/2019 | SUPPL-12 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202450s012lbl.pdf | |
11/09/2018 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202450s011lbl.pdf | |
03/16/2016 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202450s006lbl.pdf | |
04/03/2015 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202450s005lbl.pdf | |
07/17/2014 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202450s002lbl.pdf | |
07/23/2012 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202450s000lbl.pdf |