Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050789
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TOBRAMYCIN SULFATE TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE;INJECTION Prescription AP 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
07/13/2004 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50789lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50789ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/050789s000_TobramycinTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/10/2009 SUPPL-27 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050789s027ltr.pdf
02/16/2013 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

08/10/2009 SUPPL-5 Labeling Label (PDF)
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050789s005lbl.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/10/2009 SUPPL-5 Labeling Label (PDF) Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050789s005lbl.pdf
07/13/2004 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50789lbl.pdf

TOBRAMYCIN SULFATE

INJECTABLE;INJECTION; EQ 1.2GM BASE/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TOBRAMYCIN SULFATE TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 050789 FRESENIUS KABI USA
TOBRAMYCIN SULFATE TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065013 X GEN PHARMS
TOBRAMYCIN SULFATE TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 205685 XELLIA PHARMS APS

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