Drug Approvals and Databases | FDA
Sep 24, 2025 · CDER highlights key Web sites. Web page provides quick links to everything from acronyms to wholesale distributor and third-party logistics providers reporting.
Novel Drug Approvals for 2025 | FDA
Jan 2, 2026 · Novel Drug Approvals for 2025 What are "Novel" Drugs? "Novel" drugs are new drugs never before approved or marketed in the U.S.
Best Practices in Developing Proprietary Names for Human Prescription Drug Products This guidance represents the current thinking of the Food and Drug Administration (FDA or …
Find Information about a Drug | FDA
Find Drug Information on MedlinePlus Easy-to-use resource from NIH with information about side effects, dosage, special precautions, and more for prescription and OTC drugs
Approved Drug Products with Therapeutic Equivalence Evaluations ...
Dec 12, 2025 · FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) identifies drug products approved on the basis of safety and effectiveness.
Name Differentiation Project - FDA
Apr 28, 2020 · The Office of Generic Drugs requested manufacturers of sixteen look-alike name pairs to voluntarily revise the appearance of their established names in order to minimize …
Drugs | FDA - U.S. Food and Drug Administration
The Center for Drug Evaluation and Research (CDER) ensures that safe and effective drugs are available to improve the health of the people in the United States
Generic Drugs: Questions & Answers | FDA
Generic drug companies must provide scientific evidence that shows that their active ingredient is the same as that of the brand-name medicine they copy, and FDA must review that evidence.
FDA List of Authorized Generic Drugs
The FDA List of Authorized Generics page answers what an authorized generic is and how it differs from a traditional generic. An authorized generic is used to describe an approved brand …
Generic Drug Facts | FDA
Nov 1, 2021 · Generic drugs: Get the facts. Consumer-friendly text and graphics provide a few facts about generic drug approval, quality, and performance.