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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER:214047Orig1s000PRODUCT QUALITY REVIEW(S)QUALITY ASSESSMENTRecommendation: Approval 214047 Review 1 Drug Name/Dosage Form Strength Route of
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214047orig1s000 - accessdatafdagov is a form used for reporting certain information to the FDA.
Certain medical device manufacturers are required to file 214047orig1s000 - accessdatafdagov.
214047orig1s000 - accessdatafdagov should be completed following the instructions provided by the FDA.
The purpose of 214047orig1s000 - accessdatafdagov is to report specific information related to medical devices.
214047orig1s000 - accessdatafdagov requires reporting of detailed information about the medical device and its manufacturer.
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