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IS THERE A GENERIC FORM OF. Is There A ... 10 mg time release 20/6/2016 vs ...
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Generic drugs are copies of brand-name drugs that have exactly the same dosage, intended use, effects, side effects, route of administration, risks, safety, and strength as the original drug.
Pharmaceutical companies are required to file an Abbreviated New Drug Application (ANDA) for a generic drug with the FDA.
To fill out an ANDA for a generic drug, the pharmaceutical company must provide data to show that the generic drug is bioequivalent to the original drug.
The purpose of generic drugs is to provide affordable alternatives to brand-name drugs and increase competition in the pharmaceutical market.
The ANDA for a generic drug must include information on the drug's active ingredient, labeling, manufacturing process, and bioequivalence studies.
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