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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 FDC Act).
How to look up FDA numbers?
0:22 1:40 Its like your food facilitys social security number exciting right heres how you can find it.MoreIts like your food facilitys social security number exciting right heres how you can find it. First you must log into your FDA. Industry systems account this is where the magic. Happens.
How to look up FDA approved products?
To find out if a drug is approved by FDA, consumers can use two different Internet sites: Drugs@FDA lists most prescription and over-the-counter (OTC) drug products approved since 1939. The FDA Orange Book contains drugs approved by FDA under New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs).
Is Pitavastatin FDA approved?
The FDA-approved drug label for pitavastatin (LIVALO) states that it is also indicated for the treatment of adults and pediatric patients 8 years and older with heterozygous familial hypercholesterolemia (HeFH).
Is the Orange Book free to access?
The Orange Book is available online for free. This makes it easy for medical professionals to search for generic equivalents to brand-name drugs, drug patents, and drug exclusivity. Consumers can also access the Orange Book online.
Look up the drug or biological product in Drugs @ FDA. Most FDA-approved human drugs and therapeutic biological products are listed in Drugs @ FDA, a searchable database. The database allows you to search by drug name, active ingredient, or application (NDA, ANDA, or BLA) number.
Related links
RNA Detection Technology for Applications in Marine Science
by RM Ulrich The FDA recently approved DNA barcoding as a regulatory protocol to detect seafood fraud, in consortium with the Fish Barcode of Life (FISH-BOL).
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