Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 219403
Company: ZENARA PHARMA PRIVATE LTD

Products on ANDA 219403

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CENOBAMATE	CENOBAMATE	150MG	TABLET	None (Tentative Approval)	None	No	No
CENOBAMATE	CENOBAMATE	50MG	TABLET	None (Tentative Approval)	None	No	No
CENOBAMATE	CENOBAMATE	200MG	TABLET	None (Tentative Approval)	None	No	No
CENOBAMATE	CENOBAMATE	100MG	TABLET	None (Tentative Approval)	None	No	No
CENOBAMATE	CENOBAMATE	25MG	TABLET	None (Tentative Approval)	None	No	No
CENOBAMATE	CENOBAMATE	12.5MG	TABLET	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 219403

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/02/2025	ORIG-1	Tentative Approval		STANDARD		Label is not available on this site.