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APPROVED DRUG PRODUCTS will THERAPEUTIC EQUIVALENCE EVALUATIONS 18TH Edmond Cumulative Supplement 4APRIL 1998 CONTE1\'\'SPACE .0 I. I l .2 1.3l .4 l .5 1.62.0 2.1 2.2 2.3INTRODUCTION ...........................................................................................................................
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Supplement 4 - FDA refers to a type of submission made to the Food and Drug Administration for a modification to an approved drug or medical device.
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Manufacturers or sponsors of approved drugs or medical devices are required to file supplement 4 - FDA if they need to make modifications to the product.
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Information required on supplement 4 - FDA includes details about the modification, supporting data from clinical trials, safety assessments, and any potential risks.
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