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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217060
Company: LANTHEUS MEDICAL

Products on ANDA 217060

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BRAVNETSA	LUTETIUM LU-177 DOTATATE	10mCi/ML	SOLUTION;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 217060

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/27/2026	ORIG-1	Tentative Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/217060Orig1s000TAltr.pdf

Therapeutic Equivalents for ANDA 217060

BRAVNETSA

SOLUTION;INTRAVENOUS; 10mCi/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BRAVNETSA	LUTETIUM LU-177 DOTATATE	10mCi/ML	SOLUTION;INTRAVENOUS	Prescription	No	AP	217060	LANTHEUS MEDICAL

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