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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021918
Company: KEY THERAP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CETRAXAL CIPROFLOXACIN HYDROCHLORIDE EQ 0.2% BASE SOLUTION/DROPS;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
05/01/2009 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021918lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021918s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021918_cetraxal_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021918s000_SumR_P1.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
05/01/2009 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021918lbl.pdf
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