Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021395
Company: BOEHRINGER INGELHEIM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SPIRIVA TIOTROPIUM BROMIDE EQ 0.018MG BASE/INH POWDER;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
01/30/2004 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21395_spiriva_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21395ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-395_Spiriva.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/01/2018 SUPPL-48 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021395s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021395Orig1s048ltr.pdf
06/23/2016 SUPPL-44 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021395Orig1s044ltr.pdf
04/29/2016 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

03/24/2016 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

12/10/2015 SUPPL-40 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021395s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021395Orig1s040ltr.pdf
04/22/2015 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

04/23/2015 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

10/26/2015 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

11/04/2011 SUPPL-34 Labeling-Package Insert

Label is not available on this site.

07/28/2011 SUPPL-33 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021395s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021395s033ltr.pdf
12/17/2009 SUPPL-29 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021395s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021395s029ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021395Orig1s029.pdf
11/13/2008 SUPPL-27 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021395s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021395s027ltr.pdf
06/20/2008 SUPPL-22 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021395s022ltr.pdf
12/08/2006 SUPPL-15 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021395s008s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021395s008, s015ltr.pdf
03/03/2009 SUPPL-14 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021395s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021395s014ltr.pdf
12/08/2006 SUPPL-8 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021395s008s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021395s008, s015ltr.pdf
09/20/2006 SUPPL-7 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021395s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021395s007ltr.pdf
08/23/2004 SUPPL-1 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21395s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21395s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/01/2018 SUPPL-48 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021395s048lbl.pdf
12/10/2015 SUPPL-40 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021395s040lbl.pdf
07/28/2011 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021395s033lbl.pdf
12/17/2009 SUPPL-29 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021395s029lbl.pdf
03/03/2009 SUPPL-14 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021395s014lbl.pdf
11/13/2008 SUPPL-27 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021395s027lbl.pdf
12/08/2006 SUPPL-15 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021395s008s015lbl.pdf
12/08/2006 SUPPL-8 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021395s008s015lbl.pdf
09/20/2006 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021395s007lbl.pdf
08/23/2004 SUPPL-1 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21395s001lbl.pdf
01/30/2004 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21395_spiriva_lbl.pdf

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