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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018310
Company: COVIDIEN

Products on NDA 018310

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LYMPHAZURIN	ISOSULFAN BLUE	1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION;SUBCUTANEOUS	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018310

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.

Labels for NDA 018310

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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