Are scale-up and postapproval changes (SUPAC) level one and two variations and changes permitted among the three ANDA submission batches for components and composition? 1.60K viewsOctober 10, 2022FDA 0 Sam Smith11.38K November 2, 2020 0 Comments Spread the loveSpread the love 1 Answer ActiveVotedNewestOldest 0 Blogolu28.38K Posted November 2, 2020 0 Comments Spread the loveNo. The three ANDA submission batches should maintain the chosen formula based on product development studies for components and composition. Spread the love Login
