Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 071202
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.

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