do we have to revise labeling in registered in FDA after discontinuation of particulat strenght of **** product product? please advise.
i have explained e.g.below.
in one of NDA product 20 mg , 30 mg 50 mg strength are approved.
now 20 mg strength is discontinued due to buisness reason. there is dosage described in section 2 of FDA approved labelling. there are other ANDA approved based on this product. what to do? what we have to do with labelling?
please anyone can advise?
