The List is composed of four parts: (1) approved prescription drug products with therapeutic equivalence evaluations; (2) approved over-the-counter (OTC) drug products for those drugs that may not be marketed without NDAs or ANDAs because they are not covered under existing OTC monographs; (3) drug products with approval under Section 505 of the Act administered by the Center for Biologics Evaluation and Research; and (4) a cumulative list of approved products that have never been marketed, are for exportation, are for military use, have been discontinued from marketing, or have had their approvals withdrawn for other than safety or efficacy reasons subsequent to being discontinued from marketing.1 This publication also includes indices of prescription and OTC drug products by trade or established name (if no trade name exists) and by applicant name (holder of the approved application). All established names for active ingredients generally conform to official compendial names or United States Adopted Names (USAN) as prescribed in (21 CFR 299.4(e)). The latter list includes applicants’ names as abbreviated in this publication; in addition, a list of uniform terms is provided. An Addendum contains drug patent and exclusivity information for the Prescription and OTC Drug Product Lists, and for the Drug Products with Approval under Section 505 of the Act Administered by the Center for Biologics Evaluation and Research. The publication may include additional information that the Agency deems appropriate to disseminate.
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