Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204980
Company: GLENMARK PHARMS LTD

Products on ANDA 204980

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LACOSAMIDE	LACOSAMIDE	10MG/ML	SOLUTION;ORAL	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204980

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/17/2016	ORIG-1	Tentative Approval		STANDARD		Label is not available on this site.