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NDA 21107/S010 Page 3LOTRONEXPRESCRIBING INFORMATION(positron hydrochloride) Tablets WARNING: Infrequent but serious gastrointestinal adverse events have been reported with the use of CORONER. These
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Accessdatafdagov is a website managed by the Food and Drug Administration (FDA) that provides access to data related to FDA-regulated products.
Manufacturers, distributors, and other stakeholders of FDA-regulated products may be required to file information on accessdatafdagov.
To fill out accessdatafdagov, users can create an account on the website and follow the prompts to enter the required information.
The purpose of accessdatafdagov is to centralize and provide access to important data related to FDA-regulated products for regulatory and public health purposes.
Information such as product details, ingredients, manufacturing processes, labeling, and adverse events may need to be reported on accessdatafdagov.
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