What information is available for each drug product in Drugs@FDA?
• drug name (brand name or generic name) • active ingredient • dosage form or route of administration • strength • marketing status (prescription, over-the-counter, or discontinued) • company that sponsored an application for approval • FDA action date • approval type (type of supplement type or other regulatory action) Results for New Molecular Entities include: • Chemical Type (for NDAs only) • Review Classification Many, but not all drug products have links to: • current FDA approved labels • older labels • approval letters • reviews (scientific analyses of new drug applications that provide the basis for approval) • information for patients
Related Questions
- Is it permissible for a drug representative from a pharmaceutical company to give an "update" on a product before the CME activity begins?
- Can the six months of pediatric exclusivity be added to the 5 or 3 years of new drug product exclusivity?
- What information is available for each drug product in Drugs@FDA?
