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This document contains prescribing information for Sodium and Benoxinate Hydrochloride Ophthalmic Solution, including indications, dosage, contraindications, warnings, and adverse reactions.
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What is nda 211039?
NDA 211039 is a New Drug Application (NDA) submitted to the FDA for the approval of a new pharmaceutical product.
Who is required to file nda 211039?
The sponsor of the drug, typically a pharmaceutical company, is required to file NDA 211039 to seek approval for the new drug.
How to fill out nda 211039?
To fill out NDA 211039, the sponsor must complete various sections including drug information, clinical trial data, labeling, and manufacturing details according to FDA guidelines.
What is the purpose of nda 211039?
The purpose of NDA 211039 is to obtain FDA approval for a new drug to ensure it is safe and effective for public use.
What information must be reported on nda 211039?
NDA 211039 must report information including drug composition, clinical trial results, pharmacology, toxicology, manufacturing processes, and label information.
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