For access to the generic players regarding the paragraph IV patent certification filed against which product and on what date, FDA is publishing the list at the FDA website. It get updated twice in a month and provides recent updated list. The list in PDF format 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. At present list is available updated till 23 August 2010.
For more details and to dowanload complete list Click here
No comments:
Post a Comment