Information about the Products We Regulate

Contents On This Page

• New Prescription Drug Approvals
• Prescription Drug Information
• Drug Information Pathfinder
• Major Drug Information Pages
• Consumer Drug Information
• Over-the-Counter Drug Information
• Drug Safety & Side Effects
• Drug Preparedness and Bioterrorism Response
• Clinical Trials Information
• Public Health Alerts & Warning Letters
• Reports and Publications
• Special Projects & Programs

New Prescription Drug Approvals

• Drugs@FDA
• Index to Drug-Specific Information  Provides links to Consumer, Patient, and Healthcare Professional Sheets, and more.
• FDA Drug Approvals List. This is a reverse chronological listing of all drugs approved from September 1996 to August 12, 2002.
• Cancer Drug Approvals.

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.
• Biological Therapeutic Products
• Drugs to be Discontinued
• National Drug Code (NDC) Directory 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
• Inactive Ingredient Database.  The database provides information on inactive ingredients present in FDA-approved drug products. This information can be used by industry as an aid in developing drug products. 
• Index to Drug-Specific Information  Provides links to Consumer, Patient, and Healthcare Professional Sheets, and more.
• Facts@FDA Download available content of labeling in Structured Product Labeling (SPL) format.

Drug Information Pathfinder

• Drug Information Pathfinder. Provides links to information on specific drugs, drug development, drug application process, drug imports, and other topics. 

Major Drug Information Pages

For information on specific drugs, please see the Index to Drug-Specific Information.

• Antidepressant Use in Children, Adolescents, and Adults
• COX-2 Selective and Non-Selective Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
• Counter Terrorism Drugs (includes calcium-DTPA and zince-DTPA, cipro, doxycycline, levaquin, prussian blue, penicillin G procaine, and pyridostigmine bromide)
• Estrogen and Estrogen with Progestin Therapies for Postmenopausal Women
• Exocrine Pancreatic Insufficiency Drug Products
• "Fen-Phen" Information (fenfluramine, phentermine, dexfenfluramine)
• Information on Heparin
• Influenza (Flu) Antiviral Drugs
• Levothyroxine Sodium Product Information
• Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
• Pain Relievers (analgesics) and Fever Reducers (antipyretics)
• Phenylpropanolamine (PPA) Information Page
• Sleep Disorder (sedative-hypnotics) Drug Products
• Rheumatology Therapeutics

Consumer Drug Information

• Drug Information for Consumers
• Postmarket Drug Safety Information for Patients and Providers
• Index to Drug-Specific Information  Provides links to Consumer, Patient, and Healthcare Professional Sheets, and more.
• Consumer Health Information
• Analgesics: Safe Use of Over-the-Counter Pain Relievers (analgesics) and Fever Reducers (antipyretics)
• Consumer Education: What You Need to Know to Use Medicine Safely
• Drug Shortages
• Generic Drugs: Questions and Answers
• How To Obtain Domperidone
• Influenza Antiviral Drugs and Related Information
• Medication Guides
• Metered-Dose Inhalers (MDIs)
• Weight Loss Products, FDA's Initiative against Contaminated Weight Loss Products

Over-the-Counter Drug Information

• Legal Requirements for the Sale and Purchase of Drug Products Containing Pseudoephedrine, Ephedrine, and Phenylpropanolamine
• Over-the-Counter Drug Page.  Information for consumers and industry about non-prescription drugs. 

Drug Safety & Side Effects

• Postmarket Drug Safety Information for Patients and Providers
• Index to Drug-Specific Information  Provides links to Consumer, Patient, and Healthcare Professional Sheets, and more.
• Adverse Events Reporting System
• AERS Electronic Submissions
• Drug Development and Drug Interactions
• FDA Statement on the Results of the Women's Health Initiative
• Labeling Changes Related to Drug Safety. The summaries include only those safety-related sections that have been modified, and therefore do not contain all the information needed for safe and effective prescribing. Contact the manufacturer for the complete labeling/package insert.
• Medication Errors Web Page
• MedWatch The web site for the FDA Medical Products Reporting Program.
• Patient Safety (2/26/2001) Final Summary of FDA Action Items - Doing What Counts for Patient Safety: Federal Actions to Reduce Medical Errors and Their Impact
• Preventable Adverse Drug Reactions:  A Focus on Drug Interactions. Learning Module
• Reporting Adverse Reactions and Other Problems with Products Regulated by FDA.  Consumers can play an important public health role by reporting to the U.S. Food and Drug Administration any adverse reactions or other problems with products the agency regulates.

Drug Preparedness and Bioterrorism Response

• Drug Preparedness and Bioterrorism Response

Clinical Trials Information

• Information for Clinical Investigators
• Participation of Racial/Ethnic Groups in Clinical Trials and Race-Related Labeling:  A Review of New Molecular Entities Approved 1995-1999.
• ClinicalTrials.Gov  This source provides patients, families and members of the public easy access to information about the location of clinical trials, their design and purpose, criteria for participation, and, in many cases, further information about the disease and treatment under study.

Public Health Alerts & Warning Letters

• Public Health Advisories, 1997 to Present
• Alcohol Warnings for Pain Relievers and Fever Reducers (10/22/1998)
• Class Labeling for Intranasal and Orally Inhaled Corticosteroid Containing Drug Products Regarding the Potential for Growth Suppression in Children  (11/9/1998)
• FDA Enforcement Report.   The FDA Enforcement Report is published weekly by the U.S. Food and Drug Administration. It contains information on actions taken in connection with Agency regulatory activities.
• FDA Issues Alert about Misuse of Consumer Products Containing Gamma Hydroxybutyric Acid (GHB), Gamma Butyrolactone (GBL), and 1,4 Butanediol (BD) Letter. and Poster.  Optional Format: GIF. (Posted 7/22/1999)
• FDA Response to Letters Requesting Approval of Temozolomide for the Treatment of Adult Patients with Malignant Glioma at First Relapse, April 14, 1999. (Posted 4/23/1999)
• Therapeutic Equivalence of Generic Drugs Letter to Health Practitioners (2/4/1998)
• Therapeutic Equivalence of Generic Drugs Response to National Association of Boards of Pharmacy (2/6/1998)
• Warning letters and Notice of Violation Letters.  These Warning and Notice of Violation Letters, sorted by month, are supplied by the CDER Freedom of Information Office.

Reports & Publications

• Drug Safety Newsletter This publication provides postmarketing information to healthcare professionals to enhance communication of new drug safety information, raise awareness of reported adverse events, and stimulate additional adverse event reporting.
• Drug Master Files
  Drug Master Files (DMFs) are submissions to the FDA containing confidential manufacturing information about drugs, packaging materials, and excipients. The DMF lists are updated quarterly. The site also contains information about filing DMFs.
• Drug Registration and Listing System Instruction Booklet 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.
• Evaluation of Written Prescription Information Provided in Community Pharmacies, 2001 (6/18/2002)
• FDA Consumer Special Issue - From Test Tube to Patient.
  This article describes the drug approval process from a consumer perspective.

Special Projects & Programs

• FDA/CDC Partnership Addresses Unintentional Drug Overdosing
• Drug Safety
• HIV and AIDS Information. From FDA's Office of Special Health Issues
• Analgesia and Anti-inflammatory Drug Information
• Antimicrobial Resistance Page
• Antiretroviral HIV Drug Approvals and Pediatric Labeling Information
• Botanical Review Team (Botanical Drug Product Development)
• Drug-Induced Liver Toxicity
• Genomics at FDA
• Pediatric Drug Development
• Pharmaceutical cGMPs: A Risk-Based Approach
• Pharmacometrics at FDA
• Postmarketing Study Commitments
• Process Analytical Technologies (PAT) web page

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Last Updated: February 24, 2009

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