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CENTER FOR DRUG EVALUATION AND
RESEARCH
APPLICATION NUMBER:214916Orig1s000PRODUCT QUALITY REVIEW(S)QUALITYASSESSMENTRECOMMENDATION
Approval with Postmarking Commitment
Complete Response 214916
Assessment
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What is 214916orig1s000 - accessdatafdagov?
214916orig1s000 - accessdatafdagov is a unique identifier for a document related to FDA approval process.
Who is required to file 214916orig1s000 - accessdatafdagov?
The pharmaceutical company seeking FDA approval is required to file 214916orig1s000 - accessdatafdagov.
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214916orig1s000 - accessdatafdagov must be completed with all relevant information about the drug application.
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The purpose of 214916orig1s000 - accessdatafdagov is to document the review process and decision-making related to FDA approval.
What information must be reported on 214916orig1s000 - accessdatafdagov?
214916orig1s000 - accessdatafdagov must include details of the drug, clinical trials, safety data, and approval status.
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