Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 203108
Company: BOEHRINGER INGELHEIM
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 |
---|---|---|---|---|---|
05/29/2019 | SUPPL-8 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203108s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/203108Orig1s008ltr.pdf | |
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 |
---|---|---|---|---|---|
05/29/2019 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203108s008lbl.pdf | |
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 |