Key Data Files for this Active Pharmaceutical Ingredient:

Drug Master Files, 21 CFR, and other industry portals Patent/Exclusivity data file Drug Approval Drug Safety Freedom of Information Federal Register pages Pharma Companies Pharmacopeial Information Preferred API Supplier (Clients Only)

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   For the latest approval information, locate this drug using this index.