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FDA Drug Establishment Registration
 
Description of Service and Cost
 Services  Fees  Number of services  Total Fees
 Drug Establishment Registration,
 Labeler code, SPL preparation,
 Submission and US Agent.
 USD 649
 (Annually)
       $  
 Drug Listing
 USD 399 / Drug
       $  
 Label Review (Optional)
 USD 649 / Drug
       $  
Total    $  
Type of Submission (select one or both)
Drug Establishment Registration               Labeler Code Request
Establishment
                              
                 
     
     
     
Establishment Contact
     
                
     
     
     
Type of Operation
Manufacture               Repack                          Relabel                          API Manufacture               Private Label Distribution
Analytical Lab            Sterilize                               
Drug Status
OTC                               Prescription                  API                                 Veterinary                          Homeopathic
US Importer / Distributor
              
     
                          
     
 

Submitter Name        Job Title        Submitter E-mail