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U.S. Department of Health and Human Services

Drugs

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Drugs@FDA Instructions: Regulatory Information

 
How to find:
 Labels   Letters  Reviews
 Approval History
 Supplement Types
 Generics for a brand name drug
 RLD and TE codes  NDA and ANDA Numbers 
 Company   Active Ingredient

 

More Instructions:   Quick Search   Health Information   Advanced Search

 

Regulatory Information

 

First, choose an FDA Application: 

  • On the main Search page, enter the drug name or active ingredient in the search box.  If you don't know the whole name, type in as much as you know (at least three characters). You can also search by application number; however, do not enter both the number and the name. You may also click on the first letter of the drug name in the Browse Box.
  • On the Search Results page, click on your drug name.
  • On the Overview page, find your drug product by its dosage form/route and strength, and click on the drug name in the Drug Name and FDA Application Number column. This will take you to the Drug Details page for an individual application. (If there is only one application that matches your search, you will not see the Search Results or Overview page.)

The Drug Details page consists of three sections.

 

The Drug Details page consists of three sections

 

In  Section 1 you will find:

  • the Drug Name
  • the FDA application number (NDA, ANDA, BLA)
  • the Active Ingredient(s)
  • the Company (also called applicant or sponsor)   Note: Links to individual drug company web sites are not available through Drugs@FDA.
  • Original Approval Date
  • Chemical Type (for NDAs)
  • Review Classification

In  Section 2 you may find links to the following information.   Note: Not all information is available for all drug products.

1.  Therapeutic Equivalents 

This link appears for prescription drugs only. (Over-the-counter drugs will have a link called "Other OTC Drugs with the same Active Ingredient").  This link will be active only if generics or other therapeutic equivalents are available for your prescription drug product.   Note: Please read definitions for Generic Drug and Therapeutic Equivalence.

  • Click on the Therapeutic Equivalents link to go to the Therapeutic Equivalents page. This page will show you generic drug products or other brand name products that are available as  therapeutic equivalents for another prescription drug product.

    Note
    : If your drug is an over-the-counter drug product, the link will go to a page called "Over-the-Counter Drugs with the Same Active Ingredient." The products listed on that page are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

  • Products appear on the Therapeutic Equivalents page in tables by product, distinguished by dosage strength. Scroll through the tables until you find the table listing the products with the same dosage strength and form/route of administration as the drug you want to substitute. Drug products in each table are therapeutically equivalent to your drug product. 

2. Label Information

This link will take you to the most current label that FDA has in electronic format.

  • If Drugs@FDA does not have the latest approved label, you will see a link to the latest approved label that we do have.
  • There will be no link if FDA does not have a label for the drug.
  • Links to older labels appear in the Approval History section.

3. Approval History and Related Documents

This link will take you to the drug's action dates, supplement numbers, supplement types, plus links to the approval letters, reviews, labels, and patient package inserts (if available), and additional notes.

  • FDA Action dates. The action date tells when any FDA regulatory action, such as an original or supplemental approval, took place.
  • Supplement numbers.  A supplement number is associated with an existing FDA Application number (NDA, ANDA, BLA). Companies are allowed to make changes to drugs or their labels after they have been approved.  To change a label, market a new dosage or strength of a drug, or change the way it manufactures a drug, a company must submit a supplemental new drug application (sNDA).  Each sNDA is assigned a number which is usually, but not always, sequential, starting with 001.
  • Supplement Approval types. Companies are allowed to make changes to drugs or their labels after they have been approved.  To change a label, market a new dosage or strength of a drug, or change the way it manufactures a drug, a company must submit a supplemental new drug application (sNDA).   The supplement type refers to the kind of change that was approved by FDA.  This includes changes in manufacturing, patient population, and formulation.
  • Labels. (current and older) The FDA approved label is the official description of a drug product, which includes indication (what the drug is used for); who should take it; adverse events (side effects); instructions for uses in pregnant women, children, and other populations; and safety information for the patient. 
  • Approval letter. An official communication from FDA to a drug application's sponsor that allows the commercial marketing of the product.
  • Drug approval reviews. A review is the basis of FDA's decision to approve an application.  It is a comprehensive analysis of clinical trial data and other information prepared by FDA drug application reviewers.  A review is divided into sections on medical analysis, chemistry, clinical pharmacology, biopharmaceutics, pharmacology, statistics, and microbiology.
  • Patient Package Insert.  A Patient Package Insert (PPI) contains information to aid a patient's understanding of how to safely use a drug product.  It is part of the FDA-approved labeling.

In Section 3 you will find:

 

1. Strength. The strength of a drug product tells how much of the active ingredient is present in each dosage

2. Dosage Form/Route. A dosage form is the physical form in which a drug is produced and dispensed, such as a tablet, a capsule, or an injectable.

 3. Marketing Status.  Marketing status indicates how a drug product is sold in the United States.  Drug products in Drugs@FDA are identified as:

  • Prescription
  • Over-the-counter
  • Discontinued:  Drug products that have been removed from the market for reasons other than safety or effectiveness
  • None: Drug products that have been tentatively approved

4. Reference Listed Drug (RLD) identification.  Definition of RLD

  • Note:  In some cases the Reference Listed Drug is a generic drug product.

     

  • If the RLD column says "TBD," the product was recently approved, and FDA has not yet determined its Reference Listed Drug status.

5. Therapeutic Equivalence Codes (TEDefinition of TE codes

  • If the TE Code column says "None," one of the following conditions applies:
    • The product is a an Over-the-Counter (OTC) drug.
    • The product is a brand-name drug that does not have any therapeutic equivalents (There are no therapeutically equivalent generic drugs.)
    • The product was approved as a  Tentative Approval.
    • The product's marketing status is "Discontinued."
  • If the TE Code column says "TBD," the product was recently approved, and FDA has not yet determined Therapeutic Equivalence for it.