Drugs@FDA: FDA-Approved Drugs
Company: FRESENIUS KABI USA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
XYLOCAINE VISCOUS | LIDOCAINE HYDROCHLORIDE | 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION;ORAL | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
09/02/1954 | ORIG-1 | Approval | Type 3 - New Dosage Form | PRIORITY |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/24/2014 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/009470s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/009470Orig1s025ltr.pdf | |
05/31/1996 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
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04/29/1996 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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04/18/1994 | SUPPL-20 | Labeling |
Label is not available on this site. |
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02/18/1993 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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10/26/1993 | SUPPL-18 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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09/14/1989 | SUPPL-17 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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09/16/1987 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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06/20/1984 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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03/25/1982 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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07/29/1983 | SUPPL-12 | Labeling |
Label is not available on this site. |
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02/11/1981 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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05/05/1980 | SUPPL-10 | Labeling |
Label is not available on this site. |
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05/05/1980 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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12/14/1978 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/03/1977 | SUPPL-5 | Labeling |
Label is not available on this site. |
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01/12/1977 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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05/27/1976 | SUPPL-3 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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03/05/1976 | SUPPL-2 | Labeling |
Label is not available on this site. |
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05/03/1972 | SUPPL-1 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
09/24/2014 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/009470s025lbl.pdf |