Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 063116
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TOBRAMYCIN SULFATE (PHARMACY BULK) TOBRAMYCIN SULFATE EQ 40MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None No No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
05/18/1992 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
12/08/2011 SUPPL-10 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/063116s010lbl.pdf
10/04/2004 SUPPL-7 Labeling

Label is not available on this site.

10/25/2002 SUPPL-6 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

02/16/1999 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

10/03/1996 SUPPL-3 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

08/02/1994 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/08/2011 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/063116s010lbl.pdf

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