FDA Approval Activities for this Drug…

Cylert Chewable Tablets (Pemoline), 18.75, 37.5 mg, and 75 mg Abbott NDA 16-832/ S-016 5/8/98 10/23/98 Cylert Chewable Tablets (Pemoline), 37.5 mg Abbott NDA 17-703/ S-014 5/13/98 10/23/98 Cylert Indication: Treatment of Attention Deficit Disorder Pemoline Tablets, 18.75 mg, 37.5 mg, and 75 mg, only Mallinckrodt, ANDA 75-726 3/30/01 4/2/01 Pemoline Chewable Tablets, 37.5 mg, Amide Pharmaceutical, ANDA 75-678 7/26/00 11/7/00 Pemoline Chewable Tablets, 37.5 mg, Copley Pharamceutical, ANDA 75-555 2/18/00 2/24/00 Pemoline Tablets, 18.75 mg, 37.5 mg & 75 mg., Amide Pharmaceutical, ANDA 75-595 2/28/00 2/29/00 Pemoline Tablets, 18.75 mg, 37.5 mg, 75 mg, Vintage ANDA 75-328 4/19/00 4/24/00 Pemoline Tablets, 37.5 mg & 75 mg., Watson ANDA 75-287 9/18/00 10/30/00 Pemoline Tablets, 37.5 mg & 75 mg. Invamed ANDA 75-286 6/30/99 7/2/99 Pemoline Tablets, 37.5 mg, and 75 mg, only Copley Pharmaceutical, ANDA 75-030 Cylert (pemoline) Tablets and Chewable Tablets, Abbott

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