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U.S. Department of Health and Human Services

Drugs

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Drugs@FDA Instructions: Advanced Search

 
How to find:
 Drug Products by Action Dates of Approvals and Supplements
 FDA Application by Number
 Approvals and Supplements within a date range

 

More Instructions:   Quick Search    Health Information  Regulatory Information

 

Advanced Search

 

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.