From some very basic research looking at past 505b2 approvals; I assume LTP will need to provide more than just a bioequivalence study to the FDA for approval.
Also, it may be worth looking into the history of the Diazepam nasal spray (Valtoco).
https://www.pharmaipcircle.com/uncategorized/10-noteworthy-successful-505b2-launches-in-last-decade/
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