Drugs

Paragraph IV Patent Certifications

December 8, 2015

The PDF contains a list of drug products for which an Abbreviated New Drug Application (ANDA) has been received by the Office of Generic Drugs (OGD) containing a "Paragraph IV" patent certification. This list includes the name of the drug product, dosage form, strength (subject of Paragraph IV certification), reference listed drug (RLD), and the date on which the first substantially complete generic drug application was submitted to the Agency (on a prospective basis beginning 3/2/2004). The Agency will not disclose the identity of the applicant. This information will be updated twice a month and will be as current as the last update. This information should be used for reference only. The Agency will make every effort to ensure the accuracy of the information disclosed in this list. However, any discrepancies or disparities should be discussed with the Division of Filing Review at 240-402-8859, before making any decisions based on this information.

New:

Drug NameDosage FormStrengthRLDDate of Submission
Albuterol SulfateInhalation Aerosol 0.09 mg base per actuation Proventil HFA 5/20/2015
Desvenlafaxine Succinate Extended-release Tablets 25 mg Pristiq 5/8/2015
Dexmedetomidine Injection 4 mcg/mL, 20 mL vials Precedex 9/30/2015
Diclofenac Epolamine Topical Patch 1.3% Flector 6/26/2015
Granisetron Hydrochloride Transdermal System 3.1 mg/24 hrs Sancuso 10/9/2015

 

Page Last Updated: 12/09/2015
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