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An AND for an intermediate strength(s) of Cream containing sufficient data may be ... Cream USP 0.025%, the reference listed drug (RLD) or placebo.
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An ANDA stands for Abbreviated New Drug Application.
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Any company seeking to market a generic drug must file an ANDA with the FDA.
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An ANDA must include information on the generic drug's safety, efficacy, and bioequivalence to the brand-name drug.
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The purpose of an ANDA is to demonstrate that a generic drug is equivalent to a brand-name drug in all aspects.
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An ANDA must report information on the drug's active ingredients, formulation, packaging, labeling, and manufacturing process.
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