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 21395

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

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