Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 091589
Company: TEVA PHARMS USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TOBRAMYCIN TOBRAMYCIN 300MG/5ML SOLUTION;INHALATION Prescription AN 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
10/10/2013 ORIG-1 Approval Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/091589Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/091589Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/12/2016 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

10/12/2016 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

09/01/2015 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/10/2013 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/091589Orig1s000lbl.pdf

TOBRAMYCIN

SOLUTION;INHALATION; 300MG/5ML
TE Code = AN

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
KITABIS PAK TOBRAMYCIN 300MG/5ML SOLUTION;INHALATION Prescription No AN 205433 PULMOFLOW INC
TOBI TOBRAMYCIN 300MG/5ML SOLUTION;INHALATION Prescription Yes AN 050753 MYLAN SPECIALITY LP
TOBRAMYCIN TOBRAMYCIN 300MG/5ML SOLUTION;INHALATION Prescription No AN 201422 AKORN INC
TOBRAMYCIN TOBRAMYCIN 300MG/5ML SOLUTION;INHALATION Prescription No AN 205501 AMNEAL PHARMS
TOBRAMYCIN TOBRAMYCIN 300MG/5ML SOLUTION;INHALATION Prescription No AN 207080 DR REDDYS LABS SA
TOBRAMYCIN TOBRAMYCIN 300MG/5ML SOLUTION;INHALATION Prescription No AN 208964 LUPIN
TOBRAMYCIN TOBRAMYCIN 300MG/5ML SOLUTION;INHALATION Prescription No AN 209554 MYLAN
TOBRAMYCIN TOBRAMYCIN 300MG/5ML SOLUTION;INHALATION Prescription No AN 091589 TEVA PHARMS USA

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