Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062356
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GENTAMICIN SULFATE GENTAMICIN SULFATE EQ 10MG BASE/ML INJECTABLE;INJECTION Discontinued None No No
GENTAMICIN SULFATE GENTAMICIN SULFATE EQ 40MG BASE/ML INJECTABLE;INJECTION 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
03/04/1982 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
09/11/2015 SUPPL-24 Labeling-Package Insert

Label is not available on this site.

07/26/2013 SUPPL-23 Labeling-Package Insert

Label is not available on this site.

03/09/2005 SUPPL-18 Labeling

Label is not available on this site.

05/03/2004 SUPPL-17 Labeling

Label is not available on this site.

03/07/2000 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

05/21/1993 SUPPL-14 Labeling

Label is not available on this site.

02/23/1995 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

12/06/1994 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

09/07/2000 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

03/21/2000 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

03/18/1991 SUPPL-9 Labeling

Label is not available on this site.

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