Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 207986
Company: OTONOMY INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OTIPRIO CIPROFLOXACIN 6% (60MG/ML) INJECTABLE, SUSPENSION;OTIC 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
12/10/2015 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207986s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207986Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207986Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207986Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/02/2018 SUPPL-2 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207986s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207986Orig1s002ltr.pdf
01/27/2016 SUPPL-1 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207986s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207986Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/02/2018 SUPPL-2 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207986s002lbl.pdf
01/27/2016 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207986s001lbl.pdf
12/10/2015 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207986s000lbl.pdf

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