Content specific to this active ingredient… Drug Information Prescribing and patient information from leading authorities Drug Master Files Type 2 master files on file at the FDA Safety Information For prescription drugs containing this active ingredient Exclusivity Patent and market exclusivity data Federal Register FR search results for this API FDA Approved Labelling Information found in this drug's package inserts Research Links Chemical identification and research citations Title 21 Code of Federal Regulations FDA regulations for this API

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 ^ FDA's latest approval appears at the bottom of this list. ^                                                                       A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U-Z Health Topics | For Industry | DMF Index | Pharma Job Search | Pharma Company News | Best Phone © 2012 Betterchem.com