Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050753
Company: MYLAN SPECIALITY LP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TOBI TOBRAMYCIN 300MG/5ML SOLUTION;INHALATION Prescription AN Yes 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
12/22/1997 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY; Orphan Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/050753_tobi_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/20/2018 SUPPL-23 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050753s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050753Orig1s023Ltr.pdf
10/05/2018 SUPPL-22 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050753s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050753Orig1s022ltr.pdf
04/29/2016 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

10/05/2015 SUPPL-18 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050753s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050753Orig1s018ltr.pdf
04/14/2015 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

04/25/2014 SUPPL-16 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050753s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050753Orig1s016ltr.pdf
10/24/2013 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

09/26/2013 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050753s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050753Orig1s011ltr.pdf
10/16/2008 SUPPL-9 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050753s009ltr.pdf
08/05/2005 SUPPL-7 Labeling

Label is not available on this site.

09/05/2001 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/18/2000 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

03/21/2002 SUPPL-2 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50753s2ltr.pdf
09/11/1998 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/20/2018 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050753s023lbl.pdf
10/05/2018 SUPPL-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050753s022lbl.pdf
10/05/2015 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050753s018lbl.pdf
04/25/2014 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050753s016lbl.pdf
09/26/2013 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050753s011lbl.pdf

TOBI

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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