Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 220121
Company: BIOCON PHARMA LIMITED

Products on ANDA 220121

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CABOZANTINIB	CABOZANTINIB	60MG	TABLET	None (Tentative Approval)	None	No	No
CABOZANTINIB	CABOZANTINIB	20MG	TABLET	None (Tentative Approval)	None	No	No
CABOZANTINIB	CABOZANTINIB	40MG	TABLET	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 220121

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/17/2026	ORIG-1	Tentative Approval		STANDARD		Label is not available on this site.