Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 063283
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMIKACIN SULFATE AMIKACIN SULFATE EQ 62.5MG 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
10/31/1994 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
04/09/2001 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/14/1998 SUPPL-4 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

12/14/1998 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

06/18/1997 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

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