Everything You Always Wanted…(to know about approved drugs)

This is pretty geeky, but sort of irresistible.  The FDA has a database that lets you search for all kinds of information about FDA-approved brand name and generic drugs and therapeutic biological products.   It goes back to nearly all drugs approved since 1939.  It also has the drug labels, approval letters, patient information and other good stuff for almost all drug products approved since 1998.

The database — Drugs@FDA — can help you find:

  • Labels for drug products.
  • Consumer information for drugs.
  • All drugs with a specific ingredient.
  • The approval history of a drug, including approval letters and review documents.
  • Whether or not there are generic drug products for an innovator (that is, a ‘brand name’) drug product.
  • Therapeutically equivalent drug products.  These are drug products that are therapeutically equivalent, that control a symptom or condition in the exact same way as does another drug.

Handy, right?

And as you hunt down a drug product, the results will include the drug’s name;  active ingredient; its dosage form (such as capsule, tablet or injection); route of administration (oral, nasal, intramuscular and so forth); strength; and whether it is a prescription, over-the-counter or discontinued product, or tentatively approved.

The database is essentially a click-and-search operation.  It’s organized using the product’s FDA application number.  This application number is a unique tracking number (kind of like a FedEx package tracking number) assigned by the  FDA to each new drug application.   You need to know that you are likely to turn up multiple application numbers in your searches for the same drug.  If you plug in a drug’s name, each different dosage form, administration route and strength of the same drug will very likely have different application numbers.

Obviously, most of us will not have an application number when we start out, so it would be really helpful to have some other information, such as the dosage form or drug strength, to help narrow the search.

To get started, it couldn’t be simpler:  type the drug’s name or active ingredient in the search box.  Type in as much as you know of the name — at least the first three characters.  Alternatively, you can click on the first letter of the drug’s name in the browse box to bring up a list of all the possibilities starting with that letter.

Here’s where you might run into the multiple application numbers.  If there is more than one, you will go to an overview page.  Click one more time to get to all the details available about the drug.  There will also be links to all sorts of interesting related stuff: medication guides, drug safety advisories, plans to help reduce risks associated with the use of the drug (also known as a risk evaluation mitigation strategy) and so on.

Remember this is for FDA-approved medicines only — animal drugs, drugs sold outside the US not approved by the FDA and dietary supplements are not tracked in this database.

Special thanks US Department of Health and Human Services.


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