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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212680
Company: MICRO LABS

Products on ANDA 212680

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
PIRFENIDONE	PIRFENIDONE	534MG	TABLET;ORAL	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 212680

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/18/2022	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/212680Orig1s000TAltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/12/2023	SUPPL-2	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 212680

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
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	212403	LUPIN LTD
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	212403	LUPIN LTD
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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