Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 202450
Company: CIRCASSIA
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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English