Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062366
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GENTAMICIN SULFATE GENTAMICIN SULFATE EQ 40MG BASE/ML INJECTABLE;INJECTION Prescription AP No Yes
GENTAMICIN SULFATE GENTAMICIN 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
08/04/1983 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
07/26/2013 SUPPL-35 Labeling-Package Insert

Label is not available on this site.

03/07/2014 SUPPL-33 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/062366s033lbl.pdf
03/09/2005 SUPPL-26 Labeling

Label is not available on this site.

05/03/2004 SUPPL-25 Labeling

Label is not available on this site.

12/05/2002 SUPPL-24 Manufacturing (CMC)-Facility

Label is not available on this site.

12/28/2001 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

03/07/2000 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

06/22/1993 SUPPL-18 Labeling

Label is not available on this site.

08/27/1992 SUPPL-17 Labeling

Label is not available on this site.

12/06/1994 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

03/18/1991 SUPPL-15 Labeling

Label is not available on this site.

09/11/1990 SUPPL-14 Labeling

Label is not available on this site.

06/19/1991 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

11/26/1991 SUPPL-11 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
03/07/2014 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/062366s033lbl.pdf

GENTAMICIN SULFATE

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
GENTAMICIN SULFATE GENTAMICIN SULFATE EQ 40MG BASE/ML INJECTABLE;INJECTION Prescription No AP 062366 FRESENIUS KABI USA
GENTAMICIN SULFATE GENTAMICIN SULFATE EQ 40MG BASE/ML INJECTABLE;INJECTION Prescription No AP 062420 HOSPIRA

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
GENTAMICIN SULFATE GENTAMICIN SULFATE EQ 10MG BASE/ML INJECTABLE;INJECTION Prescription No AP 062366 FRESENIUS KABI USA
GENTAMICIN SULFATE GENTAMICIN SULFATE EQ 10MG BASE/ML INJECTABLE;INJECTION Prescription No AP 062420 HOSPIRA
GENTAMICIN SULFATE GENTAMICIN SULFATE EQ 10MG BASE/ML INJECTABLE;INJECTION Prescription No AP 062612 HOSPIRA

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