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Ex Libris
New Drug Information, Safety Warnings and Alerts

New Prescription Drug Approvals

  • New and Generic Drug Approvals - This is an alphabetical listing of all prescription drugs approved during 1998 through 2001.   It is updated on a daily basis and contains links to labels, approval letters, and reviews.

  • FDA Drug Approvals List.   This is a reverse chronological listing of all drugs approved since September 1996.   It is updated on a weekly basis.

  • New Drugs Approved for Cancer Indications. This is a current listing of new cancer drugs.  It is prepared by FDA's Office of Special Health Issues.

Prescription Drug Information

  • Approved Drug Products with Therapeutic Equivalence Evaluations/Orange Book. The Orange Book lists all FDA approved prescription drugs, including new and generic drugs.  The Orange Book Page includes a searchable Orange Book, as well as a text version, supplements, and downloadable data files.  It is updated on a monthly basis.

  • Drugs to be Discontinued (Updated 6/13/2002)

  • National Drug Code (NDC) Directory (Updated 4/10/2002).  The National Drug Code (NDC) System was originally established as an essential part of an out-of-hospital drug reimbursement program under Medicare. The NDC serves as a universal product identifier for human drugs. The current edition of the National Drug Code Directory is limited to prescription drugs and a few selected OTC products.

  • National Drug Code Directory Searchable Database (4/11/2002) 

Major Drug Information Pages

Consumer Drug Information

Over-the-Counter Drug Information

Drug Safety & Side Effects

Clinical Trials Information


Public Health Alerts & Warning Letters

Reports & Publications

  • Drug Master Files (4/24/2002)
    Drug Master Files (DMFs) are submissions to the FDA containing confidential manufacturing information about drugs, packaging materials, and excipients. This site contains lists of all DMFs through DMF 15913 (DMFs current as of March 30, 2002). Lists are available in Microsoft Excel and in ASCII format. . In addition, the site contains information about Type II DMFs and Abbreviated Antibiotic Drug Applications (AADAs) converted to DMFs.

  • Drug Registration and Listing System Instruction Booklet (4/16/1998).  The Drug Listing Act of 1972, amending the Federal Food, Drug, and Cosmetic Act, became effective February 1, 1973. Its purpose is to provide the Commissioner of the FDA  a current list of all drugs manufactured, prepared, propagated, compounded, or processed by a drug establishment registered under the Federal Food, Drug, and Cosmetic Act.

  • FDA Consumer Special Issue - From Test Tube to Patient.
    This article describes the drug approval process from a consumer perspective.

  • FDA's Drug Review and Approval Times (7/30/2001).

Special Projects & Programs


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