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 Drug Recalls 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… Dexmethylphenidate HCl Tablets Celgene NDA 21-278 Focalin (Dexmethylphenidate HCl) Tablets, 2.5, 5 & 10 mg Celgene NDA 21-278 TRADENAME (dexmethylphenidate HCl) 2.5 mg, 5 mg, and 10 mg Tablets, Celgene NDA 21-278 | Focalin XR (dexmethylphenidate hydrochloride) Extended-Release Capsules, Novartis Pharma, Approval | Focalin XR (dexmethylphenidate Hcl) Extended-Release Capsules, Novartis Pharma, Efficacy Supp. w/Clinical Data & Labeling Revision | Focalin XR (Dexmethylphenidate Hydrochloride) Extended-Release Capsules, Novartis Pharma, Control Suppl. & Labeling Revision | Focalin Tablet, Novartis, Labeling Revision | Dexmethylhenidate Hydrochloride Tablets, Teva Pharma, Tentative Approval | Dexmethylphenidate Hydrochloride Tablets, Teva Pharma, Approval | Focalin (dexmethylphenidate hydrochloride) Tablets, Novartis Pharma, Labeling Revision | Focalin (dexmethylphenidate HCl) Tablets, Novartis Pharma, Labeling Revision | Focalin XR (dexmethylphenidate HCl) Extended Release Capsules, Novartis Pharma, Labeling Revision ^ 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 | News Feed for each API | DMF Index | Pharma Job Search | Pharma Company News © 2008 Betterchem.com