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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021395
Company: BOEHRINGER INGELHEIM

Other Important Information from FDA

Products on NDA 021395

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	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021395

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

Labels for NDA 021395

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

Therapeutic Equivalents for NDA 021395

SPIRIVA

POWDER;INHALATION; EQ 0.018MG BASE/INH
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
SPIRIVA	TIOTROPIUM BROMIDE	EQ 0.018MG BASE/INH	POWDER;INHALATION	Prescription	Yes	AB	021395	BOEHRINGER INGELHEIM
TIOTROPIUM BROMIDE	TIOTROPIUM BROMIDE	EQ 0.018MG BASE/INH	POWDER;INHALATION	Prescription	No	AB	211287	LUPIN

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