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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208780
Company: GENENTECH INC

Products on NDA 208780

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ESBRIET	PIRFENIDONE	267MG	TABLET;ORAL	Prescription	AB	Yes	No
ESBRIET	PIRFENIDONE	534MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
ESBRIET	PIRFENIDONE	801MG	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208780

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/11/2017	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208780s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208780Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208780Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/24/2023	SUPPL-7	Labeling-Medication Guide, 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-5	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-2	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

Labels for NDA 208780

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/24/2023	SUPPL-7	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208780s007,022535s016lbl.pdf
02/24/2023	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208780s007,022535s016lbl.pdf
02/11/2022	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022535s015,208780s005lbl.pdf
07/31/2019	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022535s012,208780s002lbl.pdf
01/11/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208780s000lbl.pdf

Therapeutic Equivalents for NDA 208780

ESBRIET

TABLET;ORAL; 267MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ESBRIET	PIRFENIDONE	267MG	TABLET;ORAL	Prescription	Yes	AB	208780	GENENTECH INC
PIRFENIDONE	PIRFENIDONE	267MG	TABLET;ORAL	Prescription	No	AB	212730	ACCORD HLTHCARE
PIRFENIDONE	PIRFENIDONE	267MG	TABLET;ORAL	Prescription	No	AB	212747	AIZANT
PIRFENIDONE	PIRFENIDONE	267MG	TABLET;ORAL	Prescription	No	AB	212708	ALEMBIC
PIRFENIDONE	PIRFENIDONE	267MG	TABLET;ORAL	Prescription	No	AB	212570	AMNEAL
PIRFENIDONE	PIRFENIDONE	267MG	TABLET;ORAL	Prescription	No	AB	212709	APOTEX
PIRFENIDONE	PIRFENIDONE	267MG	TABLET;ORAL	Prescription	No	AB	212674	HETERO LABS LTD V
PIRFENIDONE	PIRFENIDONE	267MG	TABLET;ORAL	Prescription	No	AB	212722	LAURUS
PIRFENIDONE	PIRFENIDONE	267MG	TABLET;ORAL	Prescription	No	AB	212680	MICRO LABS
PIRFENIDONE	PIRFENIDONE	267MG	TABLET;ORAL	Prescription	No	AB	212772	MSN
PIRFENIDONE	PIRFENIDONE	267MG	TABLET;ORAL	Prescription	No	AB	212560	SANDOZ
PIRFENIDONE	PIRFENIDONE	267MG	TABLET;ORAL	Prescription	No	AB	212078	SCIEGEN PHARMS INC
PIRFENIDONE	PIRFENIDONE	267MG	TABLET;ORAL	Prescription	No	AB	212759	TEVA PHARMS USA

TABLET;ORAL; 801MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ESBRIET	PIRFENIDONE	801MG	TABLET;ORAL	Prescription	Yes	AB	208780	GENENTECH INC
PIRFENIDONE	PIRFENIDONE	801MG	TABLET;ORAL	Prescription	No	AB	212730	ACCORD HLTHCARE
PIRFENIDONE	PIRFENIDONE	801MG	TABLET;ORAL	Prescription	No	AB	212747	AIZANT
PIRFENIDONE	PIRFENIDONE	801MG	TABLET;ORAL	Prescription	No	AB	212708	ALEMBIC
PIRFENIDONE	PIRFENIDONE	801MG	TABLET;ORAL	Prescription	No	AB	212570	AMNEAL
PIRFENIDONE	PIRFENIDONE	801MG	TABLET;ORAL	Prescription	No	AB	212709	APOTEX
PIRFENIDONE	PIRFENIDONE	801MG	TABLET;ORAL	Prescription	No	AB	212674	HETERO LABS LTD V
PIRFENIDONE	PIRFENIDONE	801MG	TABLET;ORAL	Prescription	No	AB	212722	LAURUS
PIRFENIDONE	PIRFENIDONE	801MG	TABLET;ORAL	Prescription	No	AB	212680	MICRO LABS
PIRFENIDONE	PIRFENIDONE	801MG	TABLET;ORAL	Prescription	No	AB	212772	MSN
PIRFENIDONE	PIRFENIDONE	801MG	TABLET;ORAL	Prescription	No	AB	212560	SANDOZ
PIRFENIDONE	PIRFENIDONE	801MG	TABLET;ORAL	Prescription	No	AB	212078	SCIEGEN PHARMS INC
PIRFENIDONE	PIRFENIDONE	801MG	TABLET;ORAL	Prescription	No	AB	212759	TEVA PHARMS USA

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