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Sanctioned Providers from Participation in Maryland LAST NAMEFIRST NAMESPECIALTY1ST RESPONSE MEDICAL TRANSPORT COMPACTION DETERMINATION DATE ADDRESSHHSCITY/STATE/ZIP11/8/2016 1530 Canon Center DriveHalethorpe,
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A AMP (Abbreviated New Drug Application) is a submission to the FDA for the approval of a generic drug. It contains information about the drug's safety, effectiveness, and labeling.
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Any company looking to manufacture and sell a generic drug in the US market is required to file an AMP with the FDA.
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A company must provide detailed information about the generic drug, including its active ingredients, manufacturing process, bioequivalence data, and labeling.
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The purpose of a AMP is to demonstrate that a generic drug is equivalent to the brand-name drug in terms of safety and effectiveness.
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A company must report information on the drug's composition, manufacturing process, labeling, and bioequivalence studies.
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