More Instructions: Quick Search Health Information Regulatory Information
Click on the Advanced Search link on the main Drugs@FDA search
page to select one of three search options.
Option A - Search Drug Products by
Action Dates of Approvals and Supplements
- This search option allows you to find regulatory actions
that have occurred within a certain time range (retrieve all drug products
that have at least one Action Date falling within a range of one to three months).
- Click on Advanced Search on the main Drugs@FDA page.
- In the Option A section, enter the drug name and date range according to the instructions.
- On the Search Results page, click on your drug product name.
- On the Overview page, select a Drug Name and Application
Number. (If there is only one application that matches your search, you will not see the Search Results and Overview page.)
- On the Drug Details page, click on Approval History and
Related Documents.
- All Action Dates that fall within the date range you entered
will be highlighted.
Option B - Search by Application
Number (NDA, ANDA, BLA)
- This search option allows you to find
information on one drug product identified with an Application Number. (Note: You can also search by Application Number on the main Search Page.)
- Click on Advanced Search on the main Drugs@FDA page.
- In the Option B section, enter
the enter the six-digit number.
- Click on the drug
name from the Search Results page.
- Click on the drug product name from the Overview page to see the drug details. (If there is only one application that matches your search, you will not see the Search Results and Overview page.)
Option C - Search
by Action Dates of Approvals and Supplements
- This search option allows to find all drug products that have approval
and supplement action dates within a one, two, or three-month blocks.
- Click on Advanced Search on the main Drugs@FDA page.
- In the Option C section, select from the drop-down menu a
starting month and enter year.
- Select the number of months forward from your starting date
that you would like to search.
For example: If you select Starting Month January 2003, and select
2 months, you will be searching for drugs with Action Dates falling
between January 1, 2003 and February 28, 2003.
- On the Search Results page, click on your drug product name.
- On the Overview page, select a Drug Name and Application
Number. (If there is only one application that matches your search, you will not see the Search Results and Overview page.)
- On the Drug Details page, click on Approval History and
Related Documents.
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