Drugs@FDA: FDA-Approved Drugs
Company: FRESENIUS KABI USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| XYLOCAINE PRESERVATIVE FREE | LIDOCAINE HYDROCHLORIDE | 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| XYLOCAINE PRESERVATIVE FREE | LIDOCAINE HYDROCHLORIDE | 4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| XYLOCAINE PRESERVATIVE FREE | LIDOCAINE HYDROCHLORIDE | 10% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | No | No |
| XYLOCAINE PRESERVATIVE FREE | LIDOCAINE HYDROCHLORIDE | 20% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| XYLOCAINE PRESERVATIVE FREE | LIDOCAINE HYDROCHLORIDE | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 10/06/1969 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | 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 |
|---|---|---|---|---|---|
| 04/18/2013 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/28/2013 | SUPPL-41 | Labeling-Container/Carton Labels |
Label is not available on this site. |
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| 12/08/2000 | SUPPL-35 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 02/20/1997 | SUPPL-34 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 02/04/1997 | SUPPL-33 | Labeling |
Label is not available on this site. |
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| 05/31/1995 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 07/15/1994 | SUPPL-31 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 02/18/1993 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/11/1989 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/26/1988 | SUPPL-28 | Labeling |
Label is not available on this site. |
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| 01/19/1988 | SUPPL-27 | Labeling |
Label is not available on this site. |
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| 09/16/1987 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/04/1986 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 09/04/1986 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/03/1986 | SUPPL-23 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 09/02/1983 | SUPPL-22 | Labeling |
Label is not available on this site. |
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| 07/08/1982 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/25/1982 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 02/22/1982 | SUPPL-19 | Labeling |
Label is not available on this site. |
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| 04/27/1983 | SUPPL-18 | Labeling |
Label is not available on this site. |
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| 07/22/1982 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 07/22/1982 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 12/15/1980 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 12/07/1979 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 12/07/1979 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 12/28/1979 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/12/1978 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 09/29/1978 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 09/29/1978 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/27/1976 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 04/15/1976 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 02/12/1975 | SUPPL-4 | Labeling |
Label is not available on this site. |