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.
規制動向2026年9月13日•3分で読めます
FDA Approves ANDA078598 for Ciprofloxacin Hydrochloride Ophthalmic Solution
The FDA approved ANDA078598, submitted by J Molner, for a 0.3% ciprofloxacin hydrochloride ophthalmic solution. The product is listed as discontinued.
Pharmacountryチームがまとめました · 出典： FDA.gov
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