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Cetraxal Approval History

  • FDA approved: Yes (First approved May 1st, 2009)
  • Brand name: Cetraxal
  • Generic name: ciprofloxacin otic
  • Dosage form: Solution
  • Company: Salvat
  • Treatment for: Otitis Externa

Cetraxal (ciprofloxacin otic) is an antibiotic ear solution for the treatment of acute otitis externa.

Development History and FDA Approval Process for Cetraxal

May  1, 2009Approval FDA Approves Cetraxal Otic Solution
Nov  6, 2008Salvat Announces Submission of Complete Response to FDA Approvable Letter for Cetraxal
Sep 14, 2005Salvat Announces the FDA Acceptance of NDA for its Cetraxal Otic Solution
Jun 10, 2005SALVAT Files NDA for its Cetraxal Otic - Ciprofloxacin Otic- 0.2% Solution, for the Treatment of External Otitis
Apr 18, 2005Salvat Seeks FDA Approval for its Cetraxal Otic (Ciprofloxacin Otic) 0.2% Solution, for the Treatment of External Otitis

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