Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022535
Company: GENENTECH INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ESBRIET PIRFENIDONE 267MG 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/2014/022535s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022535Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/022535Orig1s000toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/022535Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/31/2019 SUPPL-12 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022535s012,208780s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022535Orig1s012, 208780Orig1s002ltr.pdf
01/11/2017 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022535s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022535Orig1s005ltr.pdf
01/11/2017 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

06/08/2016 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

09/24/2015 SUPPL-1 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022535s001lbl.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/31/2019 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022535s012,208780s002lbl.pdf
01/11/2017 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022535s005lbl.pdf
09/24/2015 SUPPL-1 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022535s001lbl.pdf
10/15/2014 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022535s000lbl.pdf

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