Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 206756
Company: BOEHRINGER INGELHEIM
Company: BOEHRINGER INGELHEIM
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
STIOLTO RESPIMAT | OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE | EQ 0.0025MG BASE/INH;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 |
---|---|---|---|---|---|---|---|
05/21/2015 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206756Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206756Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206756Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/29/2019 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206756s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/206756Orig1s011ltr.pdf | |
10/05/2018 | SUPPL-9 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206756s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206756Orig1s009ltr.pdf | |
06/09/2016 | SUPPL-6 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206756s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206756Orig1s006ltr.pdf | |
03/18/2016 | SUPPL-2 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206756s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206756Orig1s002ltr.pdf | |
06/16/2015 | SUPPL-1 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206756s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206756Orig1s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
05/29/2019 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206756s011lbl.pdf | |
10/05/2018 | SUPPL-9 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206756s009lbl.pdf | |
06/09/2016 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206756s006lbl.pdf | |
03/18/2016 | SUPPL-2 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206756s002lbl.pdf | |
06/16/2015 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206756s001lbl.pdf | |
05/21/2015 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206756Orig1s000lbl.pdf |