Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021936
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 No
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

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