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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021936
Company: BOEHRINGER INGELHEIM

Summary Review

Products on NDA 021936

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021936

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

Labels for NDA 021936

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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