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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
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