More Instructions: Quick Search Health Information Advanced Search
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.
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 (TE) Definition 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.
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