Cetraxal Approval History

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

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

FDA Approval History for Cetraxal

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

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Cetraxal (ciprofloxacin otic) Consumer Information

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