I have a question about proprietary names for ANDA products. I've read over the proprietary name guidance, but I cannot find any reference about having multiple approved proprietary names under 1 application or products marketed by Private Label Distributors. My question is, if an OTC product that is subject to an ANDA is marketed exclusively under private label by multiple firms, the ANDA holder must still submit each brand/proprietary name to FDA for approval, correct? Please let me know if anyone has suggestions/experience in this situation.
Thank you for your help.
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Nathan Johnston
Regulatory Affairs Associate
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