Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209801
Company: TEVA PHARMS USA INC

Products on ANDA 209801

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PERAMPANEL	PERAMPANEL	2MG	TABLET;ORAL	Prescription	AB	No	No
PERAMPANEL	PERAMPANEL	4MG	TABLET;ORAL	Prescription	AB	No	No
PERAMPANEL	PERAMPANEL	6MG	TABLET;ORAL	Prescription	AB	No	No
PERAMPANEL	PERAMPANEL	8MG	TABLET;ORAL	Prescription	AB	No	No
PERAMPANEL	PERAMPANEL	10MG	TABLET;ORAL	Prescription	AB	No	No
PERAMPANEL	PERAMPANEL	12MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 209801

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/23/2025	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209801Orig1s000TAltr.pdf

Therapeutic Equivalents for ANDA 209801

PERAMPANEL

TABLET;ORAL; 2MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FYCOMPA	PERAMPANEL	2MG	TABLET;ORAL	Prescription	Yes	AB	202834	CATALYST PHARMS
PERAMPANEL	PERAMPANEL	2MG	TABLET;ORAL	Prescription	No	AB	218178	MSN
PERAMPANEL	PERAMPANEL	2MG	TABLET;ORAL	Prescription	No	AB	209538	TARO
PERAMPANEL	PERAMPANEL	2MG	TABLET;ORAL	Prescription	No	AB	209801	TEVA PHARMS USA INC

TABLET;ORAL; 4MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FYCOMPA	PERAMPANEL	4MG	TABLET;ORAL	Prescription	Yes	AB	202834	CATALYST PHARMS
PERAMPANEL	PERAMPANEL	4MG	TABLET;ORAL	Prescription	No	AB	218178	MSN
PERAMPANEL	PERAMPANEL	4MG	TABLET;ORAL	Prescription	No	AB	209538	TARO
PERAMPANEL	PERAMPANEL	4MG	TABLET;ORAL	Prescription	No	AB	209801	TEVA PHARMS USA INC

TABLET;ORAL; 6MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FYCOMPA	PERAMPANEL	6MG	TABLET;ORAL	Prescription	Yes	AB	202834	CATALYST PHARMS
PERAMPANEL	PERAMPANEL	6MG	TABLET;ORAL	Prescription	No	AB	218178	MSN
PERAMPANEL	PERAMPANEL	6MG	TABLET;ORAL	Prescription	No	AB	209538	TARO
PERAMPANEL	PERAMPANEL	6MG	TABLET;ORAL	Prescription	No	AB	209801	TEVA PHARMS USA INC

TABLET;ORAL; 8MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FYCOMPA	PERAMPANEL	8MG	TABLET;ORAL	Prescription	Yes	AB	202834	CATALYST PHARMS
PERAMPANEL	PERAMPANEL	8MG	TABLET;ORAL	Prescription	No	AB	218178	MSN
PERAMPANEL	PERAMPANEL	8MG	TABLET;ORAL	Prescription	No	AB	209538	TARO
PERAMPANEL	PERAMPANEL	8MG	TABLET;ORAL	Prescription	No	AB	209801	TEVA PHARMS USA INC

TABLET;ORAL; 10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FYCOMPA	PERAMPANEL	10MG	TABLET;ORAL	Prescription	Yes	AB	202834	CATALYST PHARMS
PERAMPANEL	PERAMPANEL	10MG	TABLET;ORAL	Prescription	No	AB	218178	MSN
PERAMPANEL	PERAMPANEL	10MG	TABLET;ORAL	Prescription	No	AB	209538	TARO
PERAMPANEL	PERAMPANEL	10MG	TABLET;ORAL	Prescription	No	AB	209801	TEVA PHARMS USA INC

TABLET;ORAL; 12MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FYCOMPA	PERAMPANEL	12MG	TABLET;ORAL	Prescription	Yes	AB	202834	CATALYST PHARMS
PERAMPANEL	PERAMPANEL	12MG	TABLET;ORAL	Prescription	No	AB	218178	MSN
PERAMPANEL	PERAMPANEL	12MG	TABLET;ORAL	Prescription	No	AB	209538	TARO
PERAMPANEL	PERAMPANEL	12MG	TABLET;ORAL	Prescription	No	AB	209801	TEVA PHARMS USA INC