Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 205832
Company: BOEHRINGER INGELHEIM
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
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
09/06/2019 SUPPL-12 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205832s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/205832Orig1s012ltr.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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

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