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CENTER FOR DRUG EVALUATION AND RESEARCHApproval Package for: APPLICATION NUMBER: 212801Orig1s000 Trade Name: Generic or Proper Name:Asturias (osilodrostat) tablets, 1 mg, 5 mg, and 10 sponsor:NovartisApproval
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An approval package on accessdatafdagov is a collection of documents and information required for the approval process of a specific product or service.
The manufacturer or sponsor of the product or service is usually required to file the approval package on accessdatafdagov.
The approval package on accessdatafdagov is typically filled out electronically through the online portal provided by the FDA.
The purpose of the approval package on accessdatafdagov is to provide the necessary information for the FDA to evaluate and approve the product or service.
The approval package on accessdatafdagov must include detailed information about the product or service, its ingredients, manufacturing process, and any potential risks or side effects.
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