Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209877
Company: ACCORD HLTHCARE

Products on ANDA 209877

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PERAMPANEL	PERAMPANEL	2MG	TABLET;ORAL	None (Tentative Approval)	None	No	No
PERAMPANEL	PERAMPANEL	4MG	TABLET;ORAL	None (Tentative Approval)	None	No	No
PERAMPANEL	PERAMPANEL	6MG	TABLET;ORAL	None (Tentative Approval)	None	No	No
PERAMPANEL	PERAMPANEL	8MG	TABLET;ORAL	None (Tentative Approval)	None	No	No
PERAMPANEL	PERAMPANEL	10MG	TABLET;ORAL	None (Tentative Approval)	None	No	No
PERAMPANEL	PERAMPANEL	12MG	TABLET;ORAL	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 209877

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/08/2021	ORIG-1	Tentative Approval		STANDARD		Label is not available on this site.