Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065111
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
KANAMYCIN SULFATE KANAMYCIN SULFATE EQ 500MG BASE/2ML INJECTABLE;INJECTION Discontinued None No No
KANAMYCIN SULFATE KANAMYCIN SULFATE EQ 1GM BASE/3ML 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
12/17/2002 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
07/15/2015 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

03/10/2004 SUPPL-2 Labeling

Label is not available on this site.

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