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Orange Book
Content and Exclusion
The Orange Book 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 FD&C 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marketing and we have not determined that they were withdrawn from sale for safety or effectiveness reasons,
or have had their approvals withdrawn for other than safety or efficacy reasons subsequent to being discontinued from marketing.
This publication also includes indices of prescription and OTC drug products by proprietary name (brand name or trade name) or, if no proprietary name exists,
established name of the active ingredient and by applicant name, which have been abbreviated for this publication.
Established names for active ingredients generally conform to compendial names or United States Adopted Names (USAN) as described in 21 CFR 299.4 (e).
A list of uniform terms is provided in Appendix C.
The Addendum contains patent and exclusivity information for the Prescription, OTC,
Discontinued Drug Product Lists, and for the Drug Products with Approval under Section 505 of the FD&C Act Administered by the Center for Biologics Evaluation and Research.
The publication may include additional information that the Agency deems appropriate to disseminate.
Prior to the 6th Edition, the publication had excluded OTC drug products and drug products with approval under Section 505 of the FD&C Act administered by the Center for Biologics
Evaluation and Research. The Hatch Waxman Amendments required the Agency to begin publishing an up-to-date list of all marketed drug products,
OTC as well as prescription, that have been approved for safety and efficacy and for which new drug applications are required.
| Author | U.S. Food And Drug Administration |
| Language | English |
| Pages | 1681 |
| PDF Size | 10 MB |
| Category | Government |
Orange Book by FDA PDF Free Download