Orange Book Data Files
Data Descriptions updated (February 24, 2017)
Natuzen Co., Ltd. – 677942 – 03/03/2025
CGMP/Finished Pharmaceuticals/Adulterated
Natuzen Co., Ltd. – 677942 – 05/03/2024
CGMP/Finished Pharmaceuticals/Adulterated
Summary Metrics of Drug Development Tool Qualification Projects Submitted to FDA
This Table provides the current number of active CDER Drug Development Tool (DDT) Qualification projects overall and by Program (DDT-…
Patent Certifications and Suitability Petitions
Information on patents and suitability petitions that impact the availability of generic drugs.
FDA’s Labeling Resources for Human Prescription Drugs
FDA’s Labeling Resources for Human Prescription Drugs
The 23rd International Conference of Racing Analysts and Veterinarians
Drug Testing and Analysis, EarlyView.
Rapid and Accurate Identification of Fentanyl and Buprenorphine in Transdermal Patches Using QuickProbe GC–MS
This study showcases QuickProbe GC–MS as a powerful tool for identifying fentanyl and buprenorphine in transdermal patches. Our in situ extraction…
GDUFA Paid Facilities List
This list contains GDUFA facility payments received by the Agency. Data are extract from the User Fee System and GDUFA…
FDA Roundup: March 7, 2025
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.