Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 203108
Company: BOEHRINGER INGELHEIM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
STRIVERDI RESPIMAT OLODATEROL HYDROCHLORIDE EQ 0.0025MG BASE/INH SPRAY, 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
07/31/2014 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/2014/203108s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203108Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/203108Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/203108Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/02/2018 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203108s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203108Orig1s006ltr.pdf
06/09/2016 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203108s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203108Orig1s003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/02/2018 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203108s006lbl.pdf
06/09/2016 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203108s003lbl.pdf
07/31/2014 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203108s000lbl.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