Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 202450
Company: COVIS

• Summary Review

Products on NDA 202450

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 202450

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.

Labels for NDA 202450

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