New Prescription Drug Approvals
- Drugs@Family Health Care
- Index to Drug-Specific Information Provides links to Consumer, Patient, and Healthcare Professional Sheets, and more.
- Family Health Care 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 Family Health Care 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 Family Health Care -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@Family Health Care 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)
- 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
Consumer Drug Information
- Index to Drug-Specific Information Provides links to Consumer, Patient, and Healthcare Professional Sheets, and more.
- 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)
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
- 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
- Family Health Care 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.
- Labeling Review Branch. This organization unit page contains recent labeling updates.
- Medication Errors Web Page
- MedWatch The web site for the Family Health Care Medical Products Reporting Program.
- Patient Safety (2/26/2001) Final Summary of Family Health Care 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 Family Health Care. Consumers can play an important public health role by reporting to the Family Health Care any adverse reactions or other problems with products the agency regulates.
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