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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022535
Company: GENENTECH INC

Summary Review

Products on NDA 022535

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ESBRIET	PIRFENIDONE	267MG	CAPSULE;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022535

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
02/24/2023	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208780s007,022535s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208780Orig1s007;022535Orig1s016ltr.pdf
02/11/2022	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022535s015,208780s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022535Orig1s015; 208780Orig1s005ltr.pdf
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

Labels for NDA 022535

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

Therapeutic Equivalents for NDA 022535

ESBRIET

CAPSULE;ORAL; 267MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ESBRIET	PIRFENIDONE	267MG	CAPSULE;ORAL	Prescription	Yes	AB	022535	GENENTECH INC
PIRFENIDONE	PIRFENIDONE	267MG	CAPSULE;ORAL	Prescription	No	AB	212731	ACCORD HLTHCARE
PIRFENIDONE	PIRFENIDONE	267MG	CAPSULE;ORAL	Prescription	No	AB	212569	AMNEAL
PIRFENIDONE	PIRFENIDONE	267MG	CAPSULE;ORAL	Prescription	No	AB	212724	LAURUS
PIRFENIDONE	PIRFENIDONE	267MG	CAPSULE;ORAL	Prescription	No	AB	212600	SANDOZ
PIRFENIDONE	PIRFENIDONE	267MG	CAPSULE;ORAL	Prescription	No	AB	212077	SCIEGEN PHARMS INC

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