Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 215759
Company: BIOCON PHARMA LTD

Products on ANDA 215759

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LENALIDOMIDE	LENALIDOMIDE	2.5MG	CAPSULE;ORAL	None (Tentative Approval)	None	No	No
LENALIDOMIDE	LENALIDOMIDE	5MG	CAPSULE;ORAL	None (Tentative Approval)	None	No	No
LENALIDOMIDE	LENALIDOMIDE	10MG	CAPSULE;ORAL	None (Tentative Approval)	None	No	No
LENALIDOMIDE	LENALIDOMIDE	15MG	CAPSULE;ORAL	None (Tentative Approval)	None	No	No
LENALIDOMIDE	LENALIDOMIDE	20MG	CAPSULE;ORAL	None (Tentative Approval)	None	No	No
LENALIDOMIDE	LENALIDOMIDE	25MG	CAPSULE;ORAL	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 215759

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/04/2023	ORIG-1	Tentative Approval		STANDARD		Label is not available on this site.