Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018310
Company: COVIDIEN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LYMPHAZURIN ISOSULFAN BLUE 1% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No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
07/29/1981 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
10/29/2007 SUPPL-11 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018310s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018310s011ltr.pdf
07/26/2001 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

10/18/1995 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

07/13/1990 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

10/22/1987 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

10/22/1987 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

05/31/1983 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

07/27/1982 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

02/17/1982 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/29/2007 SUPPL-11 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018310s011lbl.pdf

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