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CENTER FOR DRUG EVALUATION AND RESEARCH Approval Package for: APPLICATION NUMBER:213464Orig1s000 Trade Name:LAM PIT tabletsGeneric or Proper Name:nifurtimoxSponsor:Bayer Healthcare Pharmaceuticals,
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The www.accessdata.fda.gov/213464orig1s000approval package for application contains all the information and documentation required for FDA approval of a medical product.
Manufacturers or sponsors of medical products are required to file the www.accessdata.fda.gov/213464orig1s000approval package for application.
The www.accessdata.fda.gov/213464orig1s000approval package for application must be filled out with complete and accurate information about the medical product, including its safety, efficacy, and manufacturing process.
The purpose of the www.accessdata.fda.gov/213464orig1s000approval package for application is to seek FDA approval for marketing and distribution of a medical product in the United States.
The www.accessdata.fda.gov/213464orig1s000approval package for application must include information on the medical product's safety and efficacy data, manufacturing process, labeling, and proposed usage.
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