Drugs@FDA: FDA-Approved Drugs
Company: FRESENIUS KABI USA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SENSORCAINE | BUPIVACAINE HYDROCHLORIDE | 0.75% | 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 |
---|---|---|---|---|---|---|---|
04/15/1987 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/11/2012 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
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06/30/2012 | SUPPL-14 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
06/14/2010 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
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07/21/2005 | SUPPL-10 | Labeling |
Label is not available on this site. |
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12/23/2002 | SUPPL-9 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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04/14/1997 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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05/31/1996 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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04/17/1996 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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08/29/1995 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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06/26/1996 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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09/11/1992 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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09/03/1991 | SUPPL-1 | Labeling |
Label is not available on this site. |