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- Approved_Drug_Products_with_Therapeutic_Equivalence_Evaluations abstract "The Drug, Price and Competition Act (Hatch-Waxman Act) requires FDA to publish Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book.The Orange Book identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act. The publication does not include drugs on the market approved only on the basis of safety (covered by the ongoing Drug Efficacy Study Implementation [DESI] review [e.g., Donnatal Tablets and Librax Capsules] or pre-1938 drugs [e.g., Phenobarbital Tablets]). The main criterion for the inclusion of any product is that the product is the subject of an application with an effective approval that has not been withdrawn for safety or efficacy reasons. Inclusion of products on the List is independent of any current regulatory action through administrative or judicial means against a drug product. In addition, the Orange Book contains therapeutic equivalence evaluations (2 character rating codes) for approved multisource prescription drug products (generic drugs). These evaluations have been prepared to serve as public information and advice to state health agencies, prescribers, and pharmacists to promote public education in the area of drug product selection and to foster containment of health care costs. Therapeutic equivalence evaluations in this publication are not official FDA actions affecting the legal status of products under the Act.Finally, the Orange Book lists patents that are purported to protect each drug. Patent listings and use codes are provided by the drug application owner, and the FDA is obliged to list them. In order for a generic drug manufacturer to win approval of a drug under the Hatch-Waxman Act, the generic manufacturer must certify that they will not launch their generic until after the expiration of the Orange Book-listed patent, or that the patent is invalid, unenforceable, or that the generic product will not infringe the listed patent.".
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- Approved_Drug_Products_with_Therapeutic_Equivalence_Evaluations wikiPageWikiLink Category:Food_and_Drug_Administration.
- Approved_Drug_Products_with_Therapeutic_Equivalence_Evaluations wikiPageWikiLink Drug.
- Approved_Drug_Products_with_Therapeutic_Equivalence_Evaluations wikiPageWikiLink Drug_Efficacy_Study_Implementation.
- Approved_Drug_Products_with_Therapeutic_Equivalence_Evaluations wikiPageWikiLink Drug_Price_Competition_and_Patent_Term_Restoration_Act.
- Approved_Drug_Products_with_Therapeutic_Equivalence_Evaluations wikiPageWikiLink Efficacy.
- Approved_Drug_Products_with_Therapeutic_Equivalence_Evaluations wikiPageWikiLink Federal_Food,_Drug,_and_Cosmetic_Act.
- Approved_Drug_Products_with_Therapeutic_Equivalence_Evaluations wikiPageWikiLink Food_and_Drug_Administration.
- Approved_Drug_Products_with_Therapeutic_Equivalence_Evaluations wikiPageWikiLink Generic_drug.
- Approved_Drug_Products_with_Therapeutic_Equivalence_Evaluations wikiPageWikiLink Health_care.
- Approved_Drug_Products_with_Therapeutic_Equivalence_Evaluations wikiPageWikiLink Prescription_drug.
- Approved_Drug_Products_with_Therapeutic_Equivalence_Evaluations wikiPageWikiLink State_school.
- Approved_Drug_Products_with_Therapeutic_Equivalence_Evaluations wikiPageWikiLinkText ""Orange Book"".
- Approved_Drug_Products_with_Therapeutic_Equivalence_Evaluations wikiPageWikiLinkText "Approved Drug Products with Therapeutic Equivalence Evaluations".
- Approved_Drug_Products_with_Therapeutic_Equivalence_Evaluations wikiPageWikiLinkText "FDA Orange Book".
- Approved_Drug_Products_with_Therapeutic_Equivalence_Evaluations wikiPageWikiLinkText "Orange Book".
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- Approved_Drug_Products_with_Therapeutic_Equivalence_Evaluations wikiPageUsesTemplate Template:Reflist.
- Approved_Drug_Products_with_Therapeutic_Equivalence_Evaluations subject Category:Food_and_Drug_Administration.
- Approved_Drug_Products_with_Therapeutic_Equivalence_Evaluations type Drug.
- Approved_Drug_Products_with_Therapeutic_Equivalence_Evaluations type Agency.
- Approved_Drug_Products_with_Therapeutic_Equivalence_Evaluations type Drug.
- Approved_Drug_Products_with_Therapeutic_Equivalence_Evaluations comment "The Drug, Price and Competition Act (Hatch-Waxman Act) requires FDA to publish Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book.The Orange Book identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act.".
- Approved_Drug_Products_with_Therapeutic_Equivalence_Evaluations label "Approved Drug Products with Therapeutic Equivalence Evaluations".
- Approved_Drug_Products_with_Therapeutic_Equivalence_Evaluations sameAs Q4781749.
- Approved_Drug_Products_with_Therapeutic_Equivalence_Evaluations sameAs m.0b6j5sq.
- Approved_Drug_Products_with_Therapeutic_Equivalence_Evaluations sameAs Q4781749.
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- Approved_Drug_Products_with_Therapeutic_Equivalence_Evaluations isPrimaryTopicOf Approved_Drug_Products_with_Therapeutic_Equivalence_Evaluations.