Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

        Development & Approval Process | Drugs

Drug Approvals and Databases

                        
                


                Resources for Information | Approved Drugs Home
          Drugs
          Development & Approval Process | Drugs
          Drug Approvals and DatabasesDevelopment & Approval Process | Drugs Drug Approvals and Databases
  	
        Share
    Post
    Linkedin

    Email
    Print**Acronyms and Abbreviations Search**More information
	**Approved Risk Evaluation and Mitigation Strategies (REMS)**
	**Bioresearch Monitoring Information System (BMIS) Search**More information
	**Clinical Investigator Inspection List (CLIIL) Search**More information
	**Dissolution Methods Database Search**More information
	**Drug Establishments Current Registration Site Search**More information
	**Drug Safety-related Labeling Changes (SrLC)**More information
	**Drug Shortages**More information
	**Drugs@FDA Search**More information
	**FDA Adverse Event Reporting System (FAERS) Quarterly Data Files**
	Downloadable data files.
	**FDA Adverse Event Reporting System (FAERS) Public Dashboard**


**Inactive Ingredient Search for Approved Drug Products Search**More information
	**Medication Guides Search**More information
	**National Drug Code Directory Search**More information
	**Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations) Search**More information
	**OTC Monographs@FDA**
	**Outsourcing Facility Product Report**
	**Postmarket Requirements and Commitments Search**More information
	**President's Emergency Plan for AIDS Relief (PEPFAR) Database**More Information
	**Product-Specific Guidances for Generic Drug Development Database**More Information
	**Purple Book**(database of FDA-licensed (approved) biological products, including biosimilar and interchangeable products)More Information
	**Wholesale Distributor and Third-Party Logistics Providers Reporting**More information

Resources For You

Compilation of CDER New Molecular Entity (NME) Drug and New Biologic Approvals
	Drug and Biologic Approval and IND Activity Reports
	Drug Trials Snapshots
	Oncology (Cancer) / Hematologic Malignancies Approval Notifications
	FDALabel
	FDA Online Label Repository
	FDA’s Labeling Resources for Human Prescription Drugs
	New Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products
	This Week's Drug Approvals

                                                                                  Content current as of:
      08/08/2022Drug Approvals and Databases                
                          

                        


                        Resources for Information | Approved Drugs
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop