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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208780
Company: GENENTECH INC
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ESBRIET PIRFENIDONE 534MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No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
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
02/11/2022 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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

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 PHARMS LTD
PIRFENIDONE PIRFENIDONE 267MG TABLET;ORAL Prescription No AB 212570 AMNEAL
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 INC
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 PHARMS LTD
PIRFENIDONE PIRFENIDONE 801MG TABLET;ORAL Prescription No AB 212570 AMNEAL
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 INC
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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