bioequivalence of drug combination [Regulatives / Guidelines]
As per USFDA, it is mandatory to perform separate studies for separate products.
FDA will not accept plain candesartan ANDA without BE studies.
Moreover, candesartan a BCS class II product and waiver approach (based on combination product BE study) is not possible to get the waiver for plain Candesartan.
Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe]