Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212569
Company: AMNEAL

Products on ANDA 212569

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PIRFENIDONE	PIRFENIDONE	267MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 212569

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/03/2022	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/212569Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/07/2023	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
10/11/2022	SUPPL-1	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 212569

PIRFENIDONE

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