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

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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
CURRENT STATUS - POSSIBLY EFFECTIVE - Products that were firstevaluated bY NAS/NRC and thEm bY the agency. These products werefound .to be possibly effective and required additional evidence tosUbstantiate labeling claims. Although products existed in thiscategory for the proposed List, published in January 1979, theseproducts 00 looger exist in this category because their effectivenessissues have been resolved.CURRENT STATUS - INEFFECTIVE - Products that were first evaluatedby NAS/NRC and then by the agency. These products were found tolack evidence of effectiveness and are awaiting oompletioo ofadministrative proceedings.Cl1ERENT STATUS - INEE'F'ECTlVE AS CCMBlNATIONS/NEW SAFEI'Y ISSUEprOaoctsthat were first evaluated by NAS/NRC and then by theagency. These products were fotmd to lack substantial evidence ofeffectiveness as a fixed canbinatioo and present a safety issue.They are awaiting cornpletioo of adrrdnistrative proceedings.CURRENT STATUS - "EXEMPl''' (OOURT ORDER) - Products that are subjectto paragraph XIV of Federal District Court Judge William B.Bryant's order as published in the Federal Register of December 14,1972 (37 FR 26623) • The majority of these products were firstevaluated by NAS/NRC and then later all were evaluated by FDA.These products were fotmd to be less than effective, but a decisionen whether to remove them fran the market was deferred pendingcompletien of additienal clinica~ studies.CURRENT STATUS - EFF'ECl'IVENFSS 'IO BE DEI'ERMINED - Products thatwere not reviewed bY NAS/NRC and which are tmdergoing agencyevaluatien for effectiveness.CURRENT STATUS - EE'E'EC'rIVE/NEW SAFEI'Y ISSUE - Products that werenot reviewed through the DES I process and determined to beeffective but subsequently which have been found to present a newsafety issue. These products are awaiting completion of administrativeproceedings.II - 3
Page 5: RXD AND DRUG ACMINISTRATIONAPProVED
Page 9: approved application, a list of app
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PRESCRIPTION DRUG PRODUCTS DEEMED A
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