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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER:209777Orig1s000 OTHER REVIEW(S)DATE:April 20, 2017TO:Tampa ER Capsules (NDA 208090) File Roxy bond IR Tablets (NDA 209777) Fiefdom:CDR Exclusivity
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What is xtampza er capsules nda?
Xtampza ER capsules NDA stands for New Drug Application for Xtampza ER capsules. It is a process through which drug manufacturers seek approval from the FDA to market and sell their medication.
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Drug manufacturers who want to market and sell Xtampza ER capsules are required to file the NDA with the FDA.
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Filling out the Xtampza ER capsules NDA involves submitting detailed information about the drug's safety, efficacy, manufacturing process, and labeling to the FDA for review and approval.
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The purpose of filing Xtampza ER capsules NDA is to seek approval from the FDA to market and sell the medication in the United States.
What information must be reported on xtampza er capsules nda?
The Xtampza ER capsules NDA must include information on the drug's safety, efficacy, manufacturing process, labeling, and proposed marketing plan.
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