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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 218152
Company: MSN

Products on ANDA 218152

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PERAMPANEL	PERAMPANEL	0.5MG/ML	SUSPENSION;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 218152

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/11/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 218152

PERAMPANEL

SUSPENSION;ORAL; 0.5MG/ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FYCOMPA	PERAMPANEL	0.5MG/ML	SUSPENSION;ORAL	Prescription	Yes	AB	208277	CATALYST PHARMS
PERAMPANEL	PERAMPANEL	0.5MG/ML	SUSPENSION;ORAL	Prescription	No	AB	218152	MSN

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