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NDA 211039-Page 5 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use FLUORESCEIN SODIUM AND RENOMINATE HYDROCHLORIDE OPHTHALMIC SOLUTION, 0.3%/0.4%
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NDA 211039 page 5 is a section of the New Drug Application specifying certain regulatory and administrative details required by the FDA.
Pharmaceutical companies and sponsors seeking approval for new drug applications must file NDA 211039 page 5.
To fill out NDA 211039 page 5, follow the specific instructions provided in the application guidelines, ensuring all required information is accurately included and properly formatted.
The purpose of NDA 211039 page 5 is to collect essential data and certifications that support the review and approval of the NDA by the FDA.
Information that must be reported on NDA 211039 page 5 includes the applicant's details, drug identification, and specific regulatory compliance data.
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