Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 065122
Company: FRESENIUS KABI USA
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 No
TOBRAMYCIN SULFATE TOBRAMYCIN SULFATE EQ 40MG 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
11/29/2002 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
01/29/2014 SUPPL-8 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/065122s008lbl.pdf
09/26/2005 SUPPL-4 Labeling

Label is not available on this site.

04/01/2004 SUPPL-3 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/29/2014 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/065122s008lbl.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

INJECTABLE;INJECTION; EQ 40MG 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 40MG BASE/ML INJECTABLE;INJECTION Prescription No AP 205179 AKORN
TOBRAMYCIN SULFATE TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE;INJECTION Prescription No AP 206965 BAXTER HLTHCARE CORP
TOBRAMYCIN SULFATE TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE;INJECTION Prescription No AP 065122 FRESENIUS KABI USA
TOBRAMYCIN SULFATE TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE;INJECTION Prescription No AP 063111 HOSPIRA
TOBRAMYCIN SULFATE TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE;INJECTION Prescription No AP 065407 MYLAN LABS LTD
TOBRAMYCIN SULFATE TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE;INJECTION Prescription No AP 063100 TEVA PHARMS USA
TOBRAMYCIN SULFATE TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE;INJECTION Prescription No AP 063117 WEST-WARD PHARMS INT

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