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CENTER FOR DRUG EVALUATION AND RESEARCHAPPLICATION NUMBER:203491Orig1s000 SUMMARY REVIEWED 203491 ophthalmic suspension, 0.3% Indication: For the treatment of pain and inflammation associated with
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NDA 203491 ophthalmic suspension is a medication used for ophthalmic purposes, specifically for eye infections or inflammation.
The pharmaceutical company or manufacturer is required to file NDA 203491 ophthalmic suspension with the FDA for approval.
To fill out NDA 203491 ophthalmic suspension, the company must provide detailed information about the drug's formulation, safety, and efficacy through clinical trials.
The purpose of NDA 203491 ophthalmic suspension is to provide a safe and effective treatment for eye conditions.
Information reported on NDA 203491 ophthalmic suspension includes drug composition, preclinical studies, clinical trial data, and manufacturing details.
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