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02/14/2014 CHEMISTRY REVIEWS 22360 S008 Nicorette nicotine polacrilex 2mg 4mg Mini Mint Lozenge GSK Consumer Healthcare L.P. CENTER FOR DRUG EVALUATION AND RESEARCH Approval Package for APPLICATION NUMBER NDA 22360/S-008 Name Nicorette nicotine polacrilex Mini Mint Lozenge Sponsor GlaxoSmithKline Consumer Healthcare L.P. GSKCH stated that their intention was to qualify a new sodium alginate NF supplier. GSKCH noted that the approved NMML dissolution specifications were based on the...

How to fill out nda 22360s-008

How to fill out nda 22360s-008

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What is nda 22360s-008?

NDA 22360s-008 is a form used by pharmaceutical companies to submit new drug applications to the FDA.

Who is required to file nda 22360s-008?

Pharmaceutical companies seeking approval for a new drug are required to file NDA 22360s-008.

How to fill out nda 22360s-008?

NDA 22360s-008 must be filled out according to the FDA's guidelines for new drug applications.

What is the purpose of nda 22360s-008?

The purpose of NDA 22360s-008 is to provide the FDA with all necessary information about a new drug in order to evaluate its safety and efficacy.

What information must be reported on nda 22360s-008?

NDA 22360s-008 must include information about the drug's composition, manufacturing process, clinical trials, and proposed labeling.