Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 063081
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER TOBRAMYCIN SULFATE EQ 80MG BASE/100ML INJECTABLE;INJECTION Prescription None No Yes
TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER TOBRAMYCIN SULFATE EQ 1.2MG BASE/ML INJECTABLE;INJECTION Prescription None No Yes
TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER TOBRAMYCIN SULFATE EQ 1.6MG BASE/ML INJECTABLE;INJECTION Prescription None No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/31/1990 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
09/18/2015 SUPPL-35 Labeling-Package Insert

Label is not available on this site.

12/08/2011 SUPPL-30 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/063081s030lbl.pdf
10/21/2004 SUPPL-18 Labeling

Label is not available on this site.

11/01/2002 SUPPL-17 Manufacturing (CMC)-Packaging

Label is not available on this site.

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

Label is not available on this site.

12/01/1998 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

05/02/1997 SUPPL-14 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

06/02/1997 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

03/12/1996 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

07/03/1996 SUPPL-10 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

03/11/1994 SUPPL-9 Labeling

Label is not available on this site.

05/05/1994 SUPPL-8 Labeling

Label is not available on this site.

01/14/1994 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

06/02/1993 SUPPL-6 Labeling

Label is not available on this site.

06/02/1993 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

03/10/1992 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

03/10/1992 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

01/18/1991 SUPPL-1 Manufacturing (CMC)

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-30 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/063081s030lbl.pdf

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