Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 065013
Company: X GEN PHARMS
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 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
08/17/2001 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
08/16/2013 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

11/09/2012 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

10/07/2013 SUPPL-10 Labeling

Label is not available on this site.

10/31/2012 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

10/18/2010 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

01/17/2012 SUPPL-7 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/065013s007lbl.pdf
12/09/2002 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/17/2012 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/065013s007lbl.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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