FDA

Approval Dates

Biologic License Applications

Generics

Investigational New Drug Applications

New Drug Applications

OTC Drug Applications

Center for Drug Evaluation and Research (CDER)

The mission of FDA's Center for Drug Evaluation and Research (CDER) is to ensure that drugs marketed in this country are safe and effective. CDER does not test drugs, although the Center's Office of Testing and Research does conduct limited research in the areas of drug quality, safety, and effectiveness.  

CDER is the largest of FDA's six centers.   It has responsibility for both prescription and nonprescription or over-the-counter (OTC) drugs. For more information on CDER activities, including performance of drug reviews,  post-marketing risk assessment, and other highlights, please see About the Center for Drug Evaluation and Research. The other five FDA centers have responsibility for medical and radiological devices, food and cosmetics, biologics, veterinary drugs, and tobacco products. 

Clinical Investigators

https://www.accessdata.fda.gov/scripts/cder/bmis/dsp_Search.cfm

 

Code of Federal Regulations (CFR)

Databases

1) National Drug Code Directory

2) First Generic Drug Approvals

3) Drugs@FDA

4) Orange Book (Therapeutic Equivalents)

5) Clinical Researchers

 

Drug and Biologic Approval and Investigational New Drug Activity Reports

 This list includes new drug application (NDA), biologic license application (BLA), and abbreviated new drug application (ANDA) approvals.  The list also includes a link to investigational new drug (IND) activity reports.

Fast Track Designation Requests

Finished Drugs

Food and Drug Administration

Ingredients and Appearance

1) NDC

2) 

National Drug Code

National Drug Code Directory

The Drug Listing Act of 1972 requires registered drug establishments to provide the Food and Drug Administration (FDA) with a current list of all drugs manufactured, prepared, propagated, compounded, or processed by it for commercial distribution.  (See Section 510 of the Federal Food, Drug, and Cosmetic Act (Act) (21 U.S.C. § 360)). Drug products are identified and reported using a unique, three-segment number, called the National Drug Code (NDC), which serves as a universal product identifier for drugs. FDA publishes the listed NDC numbers and the information submitted as part of the listing information in the NDC Directory which is updated daily.

The information submitted as part of the listing process, the NDC number, and the NDC Directory are used in the implementation and enforcement of the Act.

Orphan Drugs

Unfinished Drugs