FDA Approves ANDA078598 for Ciprofloxacin Hydrochloride Ophthalmic Solution

The U.S. Food and Drug Administration (FDA) has listed an Abbreviated New Drug Application (ANDA) numbered ANDA078598. The application, submitted by J Molner, concerns an ophthalmic solution/drops of ciprofloxacin hydrochloride at an equivalent strength of 0.3% base. The product is identified with product number 001 and is not a reference listed drug. The submission was an original filing (submission number 1) and received an approval status (AP) on January 16, 2008. The FDA’s record indicates the marketing status of the product as discontinued.