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This document serves as an approval letter from the FDA for the supplemental new drug applications regarding THALOMID® (thalidomide) tablets, detailing changes to labeling and safety information.
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What is NDA 20-785/S-012, S-014?
NDA 20-785/S-012, S-014 refers to a New Drug Application (NDA) submitted to the FDA for the approval of a specific medication or product.
Who is required to file NDA 20-785/S-012, S-014?
The manufacturer or sponsor of the drug seeking approval is required to file NDA 20-785/S-012, S-014.
How to fill out NDA 20-785/S-012, S-014?
To fill out NDA 20-785/S-012, S-014, the applicant must complete various sections of the application, providing detailed information on the product, clinical data, labeling, and manufacturing processes.
What is the purpose of NDA 20-785/S-012, S-014?
The purpose of NDA 20-785/S-012, S-014 is to seek FDA approval for a new drug, ensuring it is safe and effective for public use.
What information must be reported on NDA 20-785/S-012, S-014?
The information that must be reported includes clinical trial data, manufacturing methods, proposed labeling, drug stability, and safety profiles.
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