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Drugs@FDA: FDA-Approved Drugs

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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 AB Yes Yes

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
02/24/2023 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208780s007,022535s016lbl.pdf
02/11/2022 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022535s015,208780s005lbl.pdf
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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