Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 016297
Company: FRESENIUS KABI USA
Company: FRESENIUS KABI USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| XYLOCAINE 1.5% W/ DEXTROSE 7.5% | LIDOCAINE HYDROCHLORIDE | 1.5% | INJECTABLE;SPINAL | Discontinued | None | No | 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 |
|---|---|---|---|---|---|---|---|
| 11/04/1968 | 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 |
|---|---|---|---|---|---|
| 02/18/1993 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/31/1988 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 09/16/1987 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/19/1984 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 06/20/1984 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/25/1982 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/29/1979 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 05/15/1978 | SUPPL-4 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 06/28/1977 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 12/30/1974 | SUPPL-1 | Labeling |
Label is not available on this site. |