Many of the links on this page go to the Drugs@FDA Glossary.
- What is the purpose of Drugs@FDA, and what are its main uses?
- What drug products are in Drugs@FDA?
- What drug products are not in Drugs@FDA?
- Why doesn't Drugs@FDA include dietary supplements?
- How can I find out if a generic drug is available for an innovator drug?
- What information is available for each drug product in Drugs@FDA?
- How can I search Drugs@FDA?
- How do searches work in Drugs@FDA?
- How often do you update Drugs@FDA?
- Where does the information in Drugs@FDA come from?
- How does Drugs@FDA compare with the Orange Book?
- What do the Submission Classification Types for NDAs and Review Priority codes stand for?
- Can I get a copy of the Drugs@FDA database?
- How can I get further assistance?
1. What is the purpose of Drugs@FDA, and what are its main uses?
Drugs@FDA allows you to search for official information about FDA approved innovator (brand name) and generic drugs and therapeutic biological products.
The main uses of Drugs@FDA are:
- finding approved labels for approved drug products
- finding generic drug products for an innovator drug product
- finding therapeutically equivalent drug products for an innovator or generic drug product
- finding patient information for drugs approved from 1998 on
- finding all drugs with a specific active ingredient
- viewing the approval history, including approval letter(s) and review packages of a drug
2. What drug products are in Drugs@FDA?
Drugs@FDA contains prescription and over-the-counter human drugs and therapeutic biologicals currently approved for sale in the United States. Drugs@FDA includes discontinued drugs and "Submission Classification “Type 6" approvals. Not all therapeutic biological products are in Drugs@FDA.Drugs@FDA contains the following therapeutic biological products:
- monoclonal antibodies
- cytokines, growth factors, enzymes, immunomodulators; and thrombolytics
- proteins intended for therapeutic use that are extracted from animals or microorganisms, including recombinant versions of these products (except clotting factors)
- other non-vaccine therapeutic immunotherapies
Drugs@FDA contains most of the drug products approved since 1939. The majority oflabels, approval letters, reviews, and other information are available for drug products approved from 1998 to the present.
- over-the-counter (OTC) products marketed without an application by following a regulation called an OTC drug monograph.
- dietary supplements, which do not require FDA approval to be sold in the United States
- biological products regulated by the Center for Biologics Evaluation and Research
- animal drugs, which are regulated by the Center for Veterinary Medicine
- drugs not approved by FDA
- drugs sold outside the United States that are not approved for marketing in the U.S.
- drugs under review at FDA for which no action (approved or not approved) has occurred yet
4. Why doesn't Drugs@FDA include dietary supplements?
Dietary supplements do not require FDA approval to be sold in the United States. FDA's Center for Food Safety and Applied Nutrition is responsible for the agency's oversight of these products.
5. How can I find out if a generic drug is available for an innovator (sometimes called brand name) drug?
Drugs@FDA can tell you if there is a therapeutic equivalent for a prescription innovator drug or prescription generic drug.
- On the home page, search or browse using the name of the innovator drug or generic drug.
- On the Search Results page, select the drug name to open a list of drug applications. A panel will open listing one or more applications with the same drug name.
- If a generic drug is available, you will see a panel titled "Therapeutic Equivalents for NDA xxxxxx.” Click to open this panel to see the generic and other therapeutically equivalent drug products for your drug.
- Be sure to read the definitions for Generic Drug and Therapeutic Equivalents.
- Application Type (NDA, ANDA, BLA)
- Application Number
- Links to Patient Information (Medication Guide,patient package inserts)
- Product(s) on the application:
- drug name
- active ingredient
- dosage form and route of administration
- product marketing status (prescription, over-the-counter, or discontinued)
- company that sponsored an application for approval
- Links to Letters, Labels, Reviews, if available in electronic form
- Therapeutic Equivalents for prescription drugs
- For over-the-counter drugs, other OTC drugs with the same active ingredient, strength and dosage form/route
- Approval History
- For Original Approvals
- Submission Type (formerly called “chemical type”) for NDAs
- Review Priority for NDAs
- For Supplements
- Submission Type
- Approval Date
- drug name
- active ingredient
- application number (NDA, ANDA, BLA)
- original and supplemental approvals by month (“Drug Approval Reports by Month”)
8. How do searches work in Drugs@FDA?
The drugs that are listed on the "Search Results" page are not always related in terms of their chemical makeup or the conditions they treat, and are not necessarily substitutable. They appear together because their drug names or active ingredient names contain the words or parts of words you entered in the search box. The text you searched for appears in bold letters in the search results.
Even if drug products have the same active ingredient, dosage form, and strength, it might not be safe to use one in place of the other. You should always consult a health care professional to determine if one drug can be safely substituted for another, that is, if they are therapeutically equivalent.
How searches work:
- When you enter a string of characters to search Drugs@FDA, you are searching for that string of characters in the exact order you typed them, anywhere in a drug name or an active ingredient name.
If you enter "proz" you will retrieve drug products that have that four-letter string somewhere in their drug names or active ingredient names:
- CEFPROZIL [from the "Active Ingredient" column]
- OXAPROZIN POTASSIUM [from the "Active Ingredient" column]
- PROZAC [from the "Drug Name" column]
- PROZAC WEEKLY [from the "Drug Name" column]
Tip: Enter as much of the name as you know to focus your results. For example, if you know you want to retrieve the records for Prozac, enter the entire word.
- You cannot combine and Application Number searches with Drug Name or Active Ingredient searches. This search will not work: fluoxetine 018936.
9. How often do you update Drugs@FDA?
We make changes to the database every day, sometimes several times throughout the day. When we are notified that a supplement has been approved, we wait 24 hours to add the information, with the exception of special approvals.
- Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)
- Document Archiving, Reporting, and Regulatory Tracking System (DARRTS). DARRTS is used by FDA staff to track information about the receipt and review status of Investigational New Drug Applications (INDs), New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), and Biologics License Applications (BLAs) for therapeutic biologics.
11. How does Drugs@FDA compare with the Orange Book?
Drugs@FDA overlaps with the Orange Book in many aspects of content and retrieval capabilities, but it is not intended to replace the Orange Book. You can read about the origin and purpose of the Orange Book in the Preface to the Annual Edition.
- All of the drugs listed in the Orange Book appear in Drugs@FDA.
- Drugs@FDA includes information that isn’t in the Orange Book:
- Tentative Approvals and "Type 6" approvals.
- links to documents and web pages related to the approval history, drug safety, and patient information
- Therapeutic biological products(BLAs) approved by CDER
- The Orange Book includes information that isn’t in Drugs@FDA:
- Patent and exclusivity information
- The Orange Book is updated daily for new generic drug approvals and patent information and monthly for other information.
- We update Drugs@FDA daily with information on new approvals and supplemental approvals, links to documents, and the latest Orange Book data.
- Drugs@FDA provides features not available in the Orange Book, including:
- tables of therapeutic equivalents grouped by product.
- tables, grouped by product, showing over-the-counter drugs containing the same active ingredient, strength and dosage form/route of administration
- drug approval histories
- links to documents and web pages related to the approval history (including approval letters, labeling, reviews)
- links to drug safety and patient information
- drug approval reports by month
- The Orange Book provides features not available in Drugs@FDA, including:
- search by applicant (company)
- search by dosage form
- search by route of administration
- search by patent number
- filtering search results by type: prescription (Rx), over-the-counter (OTC), and discontinued
12. What do the Submission Classification Types for NDAs and Review Priority codes stand for?
For details, see FDA/CDER MAPP 5018.2
|Type 1||New molecular entity|
|Type 2||New active ingredient|
|Type 3||New dosage form|
|Type 4||New combination|
|Type 5||New formulation or other differences|
|Type 6||New indication or claim, same applicant [no longer used]|
|Type 7||Previously marketed but without an approved NDA|
|Type 8||Rx to OTC|
|Type 9||New indication or claim, drug not to be marketed under type 9 NDA after approval|
|Type 10||New indication or claim, drug to be marketed under type 10 NDA after approval|
|Type 1/4||Type 1, New molecular entity, and Type 4, New combination|
|Type 2/3||Type 2, New active ingredient, and Type 3, New dosage form|
|Type 2/4||Type 2, New active ingredient and Type 4, New combination|
|Type 3/4||Type 3, New Dosage Form, and Type 4, New combination|
13. Can I get a copy of the Drugs@FDA database?
Yes. Please see the page "Drugs@FDA Data Files" for information about the database tables and a link to the compressed file for downloading. The file does not include the scripts (programming) we use to produce the online version of Drugs@FDA. We are providing this technical information for users who are familiar with working with databases or spreadsheets.