Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020570
Company: LANTHEUS MEDICAL

Products on NDA 020570

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
QUADRAMET	SAMARIUM SM-153 LEXIDRONAM PENTASODIUM	50mCi/ML	INJECTABLE;INJECTION	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020570

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/28/1997	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/21/2017	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020570s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020570Orig1s008ltr.pdf
05/13/2009	SUPPL-4	Labeling-Container/Carton Labels, Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020570s004ltr.pdf
04/12/1999	SUPPL-2	Labeling		Label is not available on this site.
01/29/1998	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 020570

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/21/2017	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020570s008lbl.pdf