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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212759
Company: TEVA PHARMS USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PIRFENIDONE PIRFENIDONE 267MG TABLET;ORAL Prescription AB No No
PIRFENIDONE PIRFENIDONE 801MG TABLET;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/25/2022 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/212759Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/11/2022 SUPPL-1 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

PIRFENIDONE

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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