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CENTER FOR DRUG EVALUATION ANDRESEARCHAPPLICATION NUMBER:213464Orig1s000PRODUCT QUALITY REVIEW(S)RECOMMENDATION Tentative Approval with Postmarking Commitment Complete Response 213464Assessment #1
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Step 1: Visit the website www.accessdata.fda.gov/213051/orig1s000/chemrcenter
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wwwaccessdatafdagov213051orig1s000chemrcenter for drug evaluation is a form used to submit information about a drug for evaluation by the FDA.
The pharmaceutical company developing the drug is required to file wwwaccessdatafdagov213051orig1s000chemrcenter for drug evaluation.
wwwaccessdatafdagov213051orig1s000chemrcenter for drug evaluation can be filled out online through the FDA's electronic submission system.
The purpose of wwwaccessdatafdagov213051orig1s000chemrcenter for drug evaluation is to provide the FDA with detailed information about a drug for evaluation and approval.
wwwaccessdatafdagov213051orig1s000chemrcenter for drug evaluation must include information about the drug's ingredients, manufacturing process, clinical trials, and proposed labeling.
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