Drugs@FDA: FDA-Approved Drugs
Company: FRESENIUS KABI USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| XYLOCAINE 4% PRESERVATIVE FREE | LIDOCAINE HYDROCHLORIDE | 4% | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| XYLOCAINE 4% PRESERVATIVE FREE | LIDOCAINE HYDROCHLORIDE | 4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION;TOPICAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 05/07/1959 | 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 |
|---|---|---|---|---|---|
| 03/28/2013 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/28/2013 | SUPPL-31 | Labeling-Container/Carton Labels |
Label is not available on this site. |
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| 02/19/2010 | SUPPL-27 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/010417s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/010417s027ltr.pdf | |
| 03/12/1999 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 03/11/1996 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/11/1995 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/13/1996 | SUPPL-19 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 11/22/1994 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/18/1993 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/11/1989 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/16/1987 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/20/1984 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/28/1982 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/25/1982 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/25/1985 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 08/09/1982 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 08/09/1982 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/03/1980 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 12/04/1980 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 12/04/1980 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/03/1980 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/29/1979 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 06/13/1980 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 02/01/1973 | SUPPL-2 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/19/2010 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/010417s027lbl.pdf |