Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018310
Company: COVIDIEN
Company: COVIDIEN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LYMPHAZURIN | ISOSULFAN BLUE | 50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION;SUBCUTANEOUS | Discontinued | None | Yes | No |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. |
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10/18/1995 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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07/13/1990 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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10/22/1987 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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10/22/1987 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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05/31/1983 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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07/27/1982 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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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 |