Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020652
Company: IC TARGETS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TESLASCAN MANGAFODIPIR TRISODIUM 37.9MG/ML INJECTABLE;INJECTION Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/26/1997 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
07/08/2002 SUPPL-3 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20652s003ltr.pdf
03/26/1999 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

04/02/1999 SUPPL-1 Labeling

Label is not available on this site.

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