Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 063161
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TOBRAMYCIN SULFATE TOBRAMYCIN 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
05/29/1991 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
02/16/1999 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

12/10/1993 SUPPL-2 Labeling

Label is not available on this site.

05/20/1993 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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