Generic Drug Facts | FDA
2021年11月1日 · Generic drugs: Get the facts. Consumer-friendly text and graphics provide a few facts about generic drug approval, quality, and performance.
Generic Drugs: Questions & Answers | FDA - U.S. Food and Drug ...
A generic drug is a medication created to be the same as an already marketed brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and ...
Generic Drugs | FDA - U.S. Food and Drug Administration
Understanding generic drugs: Consumer-friendly information on the safe and effective use of generic drugs. Learn about the generic drug approval process, why generic drugs are usually less ...
Overview & Basics | FDA - U.S. Food and Drug Administration
The FDA Office of Generic Drugs follows a rigorous review process to make sure that, compared to the brand-name (or innovator) medications, the proposed generic medications:. Contain the same ...
Generic Drugs: What Everyone Should Know | FDA - U.S. Food and …
According to the U.S. Food and Drug Administration (FDA), a generic drug is a copy that is identical to a brand-name drug in dosage, safety, strength, how it is taken, quality, performance and ...
FDA List of Authorized Generic Drugs | FDA - U.S. Food and Drug ...
2024年10月8日 · A generic drug, as that term is commonly understood and referred to by health care providers and insurers, is a copy of a brand-name drug that is developed and made by a company other than the ...
Generic Competition and Drug Prices | FDA - U.S. Food and Drug ...
2024年10月17日 · Estimated Savings from Generic Drug Approvals. Estimating Cost Savings from New Generic Drug Approvals in 2021 (PDF, 692 KB) This study estimates savings from the 633 generic drug applications ...
2023 First Generic Drug Approvals - FDA
2024年3月8日 · In this context, a first generic application is any received ANDA: (1) That is a first-to-file ANDA eligible for 180-day exclusivity, or for which there are no blocking patents or exclusivities ...
This list of authorized generic drugs (AGs) was created from a manual review of FDA’s database of annual reports submitted to the ... Pharmaceuticals 11/19/2010 10 ACEPHEN Suppositories 120 mg G ...
2021 First Generic Drug Approvals | FDA
Generic Name ANDA Applicant Brand Name ANDA Approval Date ANDA Indication+; 93: 214051: Ivabradine Tablets, 5 mg and 7.5 mg: Centaur Pharmaceuticals Private Limited: Corlanor (Ivabradine) Tablets ...