Register a free account , and start to earn cool badges.

Find Jobs, Cars, Rentals.
Free Online Classifieds.


0 votes
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?
in Health and Beauty by  

Please log in or register to answer this question.