Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 063263
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMIKACIN SULFATE AMIKACIN SULFATE EQ 50MG 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
11/30/1994 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
03/10/2004 SUPPL-12 Labeling

Label is not available on this site.

05/13/2003 SUPPL-11 Labeling

Label is not available on this site.

10/25/2002 SUPPL-10 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

09/27/2002 SUPPL-9 Labeling

Label is not available on this site.

03/22/2001 SUPPL-8 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

03/22/2001 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/02/2000 SUPPL-6 Labeling

Label is not available on this site.

01/07/2000 SUPPL-5 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

06/18/1997 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

10/03/1996 SUPPL-2 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

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