Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 071202
Company: FRESENIUS KABI USA
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. |
||
| 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. |
||
| 07/21/2005 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 12/23/2002 | SUPPL-9 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 04/14/1997 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/31/1996 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/17/1996 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/29/1995 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/26/1996 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/11/1992 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/03/1991 | SUPPL-1 | Labeling |
Label is not available on this site. |