Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020570
Company: LANTHEUS MEDICAL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
QUADRAMET SAMARIUM SM-153 LEXIDRONAM PENTASODIUM 50mCi/ML INJECTABLE;INJECTION Prescription None Yes Yes
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-Package Insert, Labeling-Container/Carton Labels 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.

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

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