Can a prescription type material be used as a predicate for an OTC material? If so, do I need to complete a NDA? Or is this applicable only for original manufactures of the prescription?

Thank you,
Melissa

If by 'predicate' you mean 'ingredient', then sure.

My understanding is OTC drugs only need an NDA if there is no monographed description of the drug (in the USP or 21 CRF) or if there is no listing for it in the Orange book (http://www.fda.gov/cder/ob/default.htm). If it's in the Orange book you can file an ANDA. If there's no monograph or Orange book listing, then you need an ANDA. Monographed drugs don't need a drug application, but they will need a NDC number in their finial packaging.

Now, I've never taken a drug through an NDA or ANDA process, I've only been involved in monographed materials, so I may be fuzzy on certain details. Hopefully others with more experience will chime in.