APPLICATION CHECKLIST (ICH CTD)
For NDA-3 applications not submitted at the same time as the NDA-1/2 application – the NDA-1/2’s SIN number should be specified. ... should generally be included as part of the product name to allow differentiation between different products containing the same active ingredient. ... Section 18.3.2 and Appendix 10 for the registration and ... ................
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