Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 201688
Company: MYLAN SPECIALITY LP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TOBI PODHALER TOBRAMYCIN 28MG POWDER;INHALATION Prescription None 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
03/22/2013 ORIG-1 Approval Type 3 - New Dosage Form STANDARD; Orphan Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201688s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201688Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/201688Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/201688Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/27/2017 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

12/16/2016 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201688s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201688Orig1s008ltr.pdf
01/06/2016 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

10/02/2015 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201688s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201688Orig1s006ltr.pdf
09/11/2015 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

11/19/2014 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201688s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201688Orig1s004ltr.pdf
09/30/2014 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

04/25/2014 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201688s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201688Orig1s002ltr.pdf
01/07/2014 SUPPL-1 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
12/16/2016 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201688s008lbl.pdf
10/02/2015 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201688s006lbl.pdf
11/19/2014 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201688s004lbl.pdf
04/25/2014 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201688s002lbl.pdf
03/22/2013 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201688s000lbl.pdf

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