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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 205832
Company: BOEHRINGER INGELHEIM

Summary Review

Products on NDA 205832

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OFEV	NINTEDANIB ESYLATE	EQ 100MG BASE	CAPSULE;ORAL	Prescription	None	Yes	No
OFEV	NINTEDANIB ESYLATE	EQ 150MG BASE	CAPSULE;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 205832

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/15/2014	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205832s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205832Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205832Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205832Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/13/2022	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205832Orig1s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/205832Orig1s016ltr.pdf
10/28/2020	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205832s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/205832Orig1s014ltr.pdf
03/09/2020	SUPPL-13	Efficacy-New Indication	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205832s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/205832Orig1s013ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/205832Orig1s013.pdf
09/06/2019	SUPPL-12	Efficacy-New Indication	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205832s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/205832Orig1s012ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/205832Orig1s012.pdf
11/09/2018	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205832s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205832Orig1s010ltr.pdf
01/29/2018	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205832s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205832Orig1s009ltr.pdf
12/13/2017	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205832s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205832Orig1s007ltr.pdf
08/04/2017	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205832s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205832Orig1s005ltr.pdf
02/09/2017	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205832s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205832Orig1s004ltr.pdf
06/16/2016	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
02/04/2016	SUPPL-1	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205832s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205832Orig1s001ltr.pdf

Labels for NDA 205832

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/13/2022	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205832Orig1s016lbl.pdf
10/28/2020	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205832s014lbl.pdf
03/09/2020	SUPPL-13	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205832s013lbl.pdf
09/06/2019	SUPPL-12	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205832s012lbl.pdf
11/09/2018	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205832s010lbl.pdf
01/29/2018	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205832s009lbl.pdf
12/13/2017	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205832s007lbl.pdf
08/04/2017	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205832s005lbl.pdf
02/09/2017	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205832s004lbl.pdf
02/04/2016	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205832s001lbl.pdf
02/04/2016	SUPPL-1	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205832s001lbl.pdf
10/15/2014	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205832s000lbl.pdf

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