FDA orange book [electronic resource] : approved drug products with therapeutic equivalence evaluation (monthly cumulative supplement).
The publication, Approved drug products with therapeutic equivalence evaluations (the List, commonly known as 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 Act...
Saved in:
| Online Access: |
Law Students, Faculty, and Staff (via Lexis+) |
|---|---|
| Other title: | Cumulative supplement for approved drug products with therapeutic equivalence evaluations (orange book) Approved drug products with therapeutic equivalence evaluation (monthly cumulative supplement) Lexis+ online Lexis+ online. |
| Format: | Electronic Website |
| Language: | English |
| Published: |
[Washington, District of Columbia] :
U.S. Food and Drug Administration
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| Subjects: |
MARC
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| 245 | 0 | 0 | |a FDA orange book |h [electronic resource] : |b approved drug products with therapeutic equivalence evaluation (monthly cumulative supplement). |
| 246 | 3 | |a Cumulative supplement for approved drug products with therapeutic equivalence evaluations (orange book) | |
| 246 | 3 | 0 | |a Approved drug products with therapeutic equivalence evaluation (monthly cumulative supplement) |
| 264 | 1 | |a [Washington, District of Columbia] : |b U.S. Food and Drug Administration | |
| 264 | 2 | |a [Place of distribution not identified] : |b [LexisNexis], |c [2011]- | |
| 300 | |a 1 online resource | ||
| 310 | |a Updated monthly | ||
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| 588 | |a Description based on source information screen, viewed November 2, 2020. | ||
| 520 | |a The publication, Approved drug products with therapeutic equivalence evaluations (the List, commonly known as 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 Act). 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]) are not included in this publication. 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 List contains therapeutic equivalence evaluations for approved multisource prescription drug products. 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. | ||
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