ANDA:
Abbreviated New Drug Applications (ANDA) are the generally valid approach to market approval for drugs only in the case, in which the same active ingredient(s), dosage form, strength, route of administration, and conditions of use are present. This, in fact depicts a case, as an example, whereas a pre-filled syringe has been used and is newly used in an auto-injector.
To claim the ANDA route, safety and effectiveness must be shown to the “former” product as well as bio-equivalency to the reference listed drug (RLD). This is due to the fact, that the ANDA is relying on the safety and effectiveness of the RLD, instead of being required to collect data on the new product.
In any case, the constituent part(s) must be documented and underpinned with sufficient data to show compatibility for use with the final product’s formulation.