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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 AB 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

CETRAXAL

SOLUTION/DROPS;OTIC; EQ 0.2% BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CETRAXAL CIPROFLOXACIN HYDROCHLORIDE EQ 0.2% BASE SOLUTION/DROPS;OTIC Prescription Yes AB 021918 KEY THERAP
CIPROFLOXACIN HYDROCHLORIDE CIPROFLOXACIN HYDROCHLORIDE EQ 0.2% BASE SOLUTION/DROPS;OTIC Prescription No AB 217887 IDENTIRX
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