FDA Approval Packages contain Reviews, Labels, and Approval Histories (Administrative Documents, Approval Letters, Correspondence)*:

Reviews: the basis of the FDA's decision to approve an application. It is a comprehensive analysis of clinical trial data and other information prepared by FDA drug application reviewers. A review is divided into sections on medical analysis, chemistry, clinical pharmacology, biopharmaceutics, pharmacology, statistics and microbiology.

Labels: The FDA approved label is the official description of a drug product which includes indication (what the drug is used for); who should take it; adverse events (side effects); instructions for uses in pregnancy, children, and other populations; and safety information for the patient. Labels are often found inside drug product packaging.

Approval Histories (Administrative Documents, Approval Letters, Correspondence): The approval history is a chronological list of all FDA actions involving one drug product having a particular FDA Application number (NDA). There are over 50 kinds of approval actions including changes in the labeling, a new route of administration, and a new patient population for a drug product.

Reference to FDA Classic

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*descriptions from USFDA website

 

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