Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021936
Company: BOEHRINGER INGELHEIM
Company: BOEHRINGER INGELHEIM
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SPIRIVA RESPIMAT | TIOTROPIUM BROMIDE | EQ 0.0025MG BASE/INH | SPRAY, METERED;INHALATION | Prescription | None | Yes | Yes |
SPIRIVA RESPIMAT | TIOTROPIUM BROMIDE | EQ 0.00125MG 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 |
---|---|---|---|---|---|---|---|
09/24/2014 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021936s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021936Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/021936Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/021936Orig1s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/14/2019 | SUPPL-12 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021936s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021936Orig1s012ltr.pdf | |
02/15/2017 | SUPPL-7 | Efficacy-New Patient Population |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021936s007lbl.pdf | |
06/09/2016 | SUPPL-5 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021936s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021936Orig1s005ltr.pdf | |
01/15/2016 | SUPPL-3 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021936s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021936Orig1s003ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
02/14/2019 | SUPPL-12 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021936s012lbl.pdf | |
02/15/2017 | SUPPL-7 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021936s007lbl.pdf | |
06/09/2016 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021936s005lbl.pdf | |
01/15/2016 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021936s003lbl.pdf | |
09/24/2014 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021936s000lbl.pdf |