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July 30 2014 Priority includes pediatric data January 30 2015 PAZEO hydrochloride ophthalmic solution 0. The NDA 20-688 was approved December 18 1996. The IND is IND 44216. hydrochloride ophthalmic solution 0. 7. After internal discussion CMC confirmed the name and concentration should be PAZEO hydrochloride ophthalmic solution 0. This container/closure system is the same as use for and by Alcon. The product has a 2. Resulted in mean SD range steady state plasma Cmax and AUC0-12 of 1. 6 0. 9...
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