This message was posted by a user wishing to remain anonymous
In this situation, an
OTC generic product has been marketed in the US
without a proprietary name for a period of time. Now, a decision has been made to add a proprietary name to the product labeling. What is the process for implementing a proprietary name, once it is selected by the ANDA holder? Does this proprietary name need to be reviewed by the FDA via an ANDA supplement or via the ANDA annual report?
Thank you in advance for your time and consideration!