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2. To Use only with an DSIR DS or INOvent operated by trained personnel 2. 2 Do not discontinue abruptly 2. O. Box 9001 USA 2013 INO Therapeutics OTHER REVIEW S NDA 20 945 Products Label Review Name of Drug nitric oxide Sponsor/Monitors INO Therapeutics Date of Submission 6/25/12 Date Review Completed 11/26/12 Reviewer Gail Moreschi M. D. MPH FACP was originally approved by the FDA on December 23 1999. The current label is dated July 2011. Fda.gov/AboutFDA/CentersOffices/CDER/ucm090142. htm....

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What is nda 20845 s-14?

NDA 20845 s-14 is a form used to submit information to the regulatory agency for a specific pharmaceutical product.

Who is required to file nda 20845 s-14?

The pharmaceutical company that holds the marketing authorization for the product is required to file NDA 20845 s-14.

How to fill out nda 20845 s-14?

NDA 20845 s-14 must be completed with detailed information about the product, including safety and efficacy data, manufacturing process, and labeling information.

What is the purpose of nda 20845 s-14?

The purpose of NDA 20845 s-14 is to provide the regulatory agency with updated information about the pharmaceutical product to ensure its safety and effectiveness.

What information must be reported on nda 20845 s-14?

Information such as adverse events, changes in manufacturing process, labeling updates, and any new safety or efficacy data must be reported on NDA 20845 s-14.