first edition (1980) of the Orange Book - FDA Law Blog

underlining/bolding within that specific dosage form heading for codesbeginning with II A") . For further clar ificatioo see the annotatedexanples at the end of this sectioo. ~2. Trade Name IndexThe Trade Name Index is a list of products by trade name or genericname. It also indicates the ingredient under which product informatioocan be found in the Drug Product List.3. Application Holder IndexThe Applicatioo Holder Index is an index of products by applicatiooholders. It also indicates the first alphabetically arranged ingredientunder which product informatioo can be found in the Drug Product List.4. Application Holder Abbreviation ListThe Applicatioo Holder Abbreviatioo List is an index of theapplication holder name abbreviatioos used in the lists.5. Appendix: Prescription Drug Products Deemed Approved - PendingResolution of Safety or Effectiveness IssuesThe drug products in this appendix were either originally approvedfor safety between 1938 and 1962 or were approved subsequently as beingidentical, similar, or related to those drug products. They do notawear in the Drug Prodoct List because they have not received a finaldetermination of effectiveness under the Drug Efficacy StudyImplementation (DESI) review, or were not reviewed under DESI but areunder evaluatioo by' the agency for safety issues. They are listedalphabetically by' trade name. The application holder's name and firstalphabetically listed active ingredient are also included.The awendix is divided into the following classifications:CURRENT STA'lUS - PROBABLY EF'FECI'IVE - Products that were firstevaluated by the National Academy of Sciences, National ResearchCouncil (NAS/NRC) and then by' the agency. These products werefourrl to be probably effective and require additional evidence tosubstantiate labeling claims.II - 2