An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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
10/11/2024	SUPPL-28	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/205832s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/205832Orig1s028ltr.pdf
06/18/2024	SUPPL-27	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/205832s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/205832Orig1s027ltr.pdf
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-Patient Package Insert, Labeling-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
10/11/2024	SUPPL-28	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/205832s028lbl.pdf
06/18/2024	SUPPL-27	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/205832s027lbl.pdf
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-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205832s001lbl.pdf
02/04/2016	SUPPL-1	Labeling-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

Top