Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 063112
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TOBRAMYCIN SULFATE TOBRAMYCIN SULFATE EQ 10MG BASE/ML INJECTABLE;INJECTION Prescription AP 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
04/30/1991 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
09/18/2015 SUPPL-19 Labeling-Package Insert

Label is not available on this site.

01/12/2012 SUPPL-15 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/063112Orig1s015lbl.pdf
04/07/2005 SUPPL-11 Labeling

Label is not available on this site.

04/07/2005 SUPPL-10 Labeling

Label is not available on this site.

04/27/2004 SUPPL-9 Labeling

Label is not available on this site.

10/25/2002 SUPPL-8 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

02/16/1999 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

10/03/1996 SUPPL-5 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

12/10/1993 SUPPL-3 Labeling

Label is not available on this site.

04/02/1993 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

11/15/1991 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
01/12/2012 SUPPL-15 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/063112Orig1s015lbl.pdf

TOBRAMYCIN SULFATE

INJECTABLE;INJECTION; EQ 10MG BASE/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TOBRAMYCIN SULFATE TOBRAMYCIN SULFATE EQ 10MG BASE/ML INJECTABLE;INJECTION Prescription No AP 065122 FRESENIUS KABI USA
TOBRAMYCIN SULFATE TOBRAMYCIN SULFATE EQ 10MG BASE/ML INJECTABLE;INJECTION Prescription No AP 063112 HOSPIRA

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