FDA Approval Activities for this Drug…

Concerta (methylphenidate HCl) Extended-release Tablets, Alza Corp. NDA 21-121/S4 4/1/02 4/11/02 Concerta (methylphenidate HCl) Extended-release Tablets, 18 mg & 36 mg, Alza Corp. NDA 21-121 8/1/00 8/4/00 8/4/00 5/25/01 Concerta Indications: for once daily treatment of attention deficit disorder. Metadate CD (methylphenidate hydrochloride) Extended-release Capsules, Celltech NDA 21-259/S8 9/22/03 9/29/03 Metadate CD (methylphenidate hydrochloride) Extended-release Capsules, Celltech NDA 21-259/S6 6/19/03 7/8/03 Metadate CD (methylphenidate hydrochloride USP) Extended-release Capsules, 20 mg. Celltech NDA 21-259 4/03/01 4/9/03 5/9/03 Metadate CD (methylphenidate HCl USP) Extended-release Capsules, Celltech NDA 21-259/S-001 4/9/02 4/16/02 4/9/02 Metadate ER tablets (methylphenidate HCl) USP, 10 mg Medeva ANDA 40-306 Methylin (methylphenidate hydrochloride) Chewable Tablets, 2.5 mg, 5.0 mg and 10 mg, Mallinckrodt, NDA 21-475 4/15/03 4/18/03 Methylin (methylphenidate hydrochloride) Solution, 5 mg/5 mL and 10 mg/5 mL Mallinckrodt, NDA 21-419 12/19/02 1/29/03 Methylin ER Tablets (Methylphenidate Hydrochloride Extended-release Tablets USP), 10 mg and 20 mg. Mallinckrodt, ANDA 75-629 5/9/00 5/22/00 12/5/01 Methylphenidate Hydrochloride Extended-release Tablets USP, 10 mg, & 20 mg, Purepac Pharmaceutical Co. ANDA 75-450 12/21/01 Methylphenidate Hydrochloriade Extended-release Tablets USP, 10mg, & 20 mg, Able, ANDA 76-032 5/9/01 6/5/01 Methylphenidate Hydrochloride Extended-release Tablets USP, 20 mg, Danbury Pharmacal, ANDA 40-410 2/9/01 3/5/01 Methylphenidate Hydrochloride Tablets USP, 5 mg, 10mg, & 20 mg, Able, ANDA 40-404 3/29/01 3/30/01 Methylphenidate Hydrochloride Tablets USP, 5 10 & 20 mg, Purepac Pharmaceutical Co. ANDA 40-321 2/5/02 4/8/03 Methylphenidate Hydrochloride Tablets USP, 5 mg, 10mg, & 20 mg Mallinckrodt ANDA 40-300 Ritalin LA (methylphenidate hydrochloride) Extended-release Capsules, Novartis NDA 21-284 6/5/02 6/17/02 6/7/02 11/20/02 Ritalin (methylphenidate hydrochloride) and Ritalin-SR Sustained-release Tablets Novartis NDA 10-187/S-060 & 18-029/S-032 METHYLPHENIDATE HYDROCHLORIDE Capsule, Extended Release; 10MG METADATE CD CELLTECH 021259 BX METHYLPHENIDATE HYDROCHLORIDE Capsule, Extended Release; 20MG METADATE CD CELLTECH 021259 BX METHYLPHENIDATE HYDROCHLORIDE Capsule, Extended Release; 30MG METADATE CD CELLTECH 021284 BX METHYLPHENIDATE HYDROCHLORIDE Capsule, Extended Release; 20MG RITALIN LA NOVARTIS 021284 BX METHYLPHENIDATE HYDROCHLORIDE Capsule, Extended Release; 30MG RITALIN LA NOVARTIS 021284 METHYLPHENIDATE HYDROCHLORIDE Capsule, Extended Release; 40MG RITALIN LA NOVARTIS 021419 METHYLPHENIDATE HYDROCHLORIDE Solution; 10MG/5ML METHYLIN Mallinckrodt BAKER 021419 METHYLPHENIDATE HYDROCHLORIDE Solution; 5MG/5ML METHYLIN Mallinckrodt BAKER 021475 METHYLPHENIDATE HYDROCHLORIDE Tablet, Chewable; 10MG METHYLIN Mallinckrodt 021475 METHYLPHENIDATE HYDROCHLORIDE Tablet, Chewable; 2.5MG METHYLIN Mallinckrodt 021475 METHYLPHENIDATE HYDROCHLORIDE Tablet, Chewable; 5MG METHYLIN Mallinckrodt 076032 METHYLPHENIDATE HYDROCHLORIDE Tablet, Extended Release; 20MG METHYLPHENIDATE HCL Able 089601 METHYLPHENIDATE HYDROCHLORIDE Tablet, Extended Release; 20MG METADATE ER CELLTECH MFG 040306 METHYLPHENIDATE HYDROCHLORIDE Tablet, Extended Release; 10MG METADATE ER CELLTECH 075629 METHYLPHENIDATE HYDROCHLORIDE Tablet, Extended Release; 10MG METHYLIN ER Mallinckrodt 075629 METHYLPHENIDATE HYDROCHLORIDE Tablet, Extended Release; 20MG METHYLIN ER Mallinckrodt 021121 METHYLPHENIDATE HYDROCHLORIDE Tablet, Extended Release; 18MG CONCERTA MCNEIL CONS SPECLT 021121 METHYLPHENIDATE HYDROCHLORIDE Tablet, Extended Release; 27MG CONCERTA MCNEIL CONS SPECLT 021121 METHYLPHENIDATE HYDROCHLORIDE Tablet, Extended Release; 36MG CONCERTA MCNEIL CONS SPECLT 021121 METHYLPHENIDATE HYDROCHLORIDE Tablet, Extended Release; 54MG CONCERTA MCNEIL CONS SPECLT 018029 METHYLPHENIDATE HYDROCHLORIDE Tablet, Extended Release; 20MG RITALIN-SR NOVARTIS 075450 METHYLPHENIDATE HYDROCHLORIDE Tablet, Extended Release; 20MG METHYLPHENIDATE HCL Purepac 040410 METHYLPHENIDATE HYDROCHLORIDE Tablet, Extended Release; 20MG METHYLPHENIDATE HCL Watson 040404 METHYLPHENIDATE HYDROCHLORIDE Tablet; 10MG METHYLPHENIDATE HCL Able 040404 METHYLPHENIDATE HYDROCHLORIDE Tablet; 20MG METHYLPHENIDATE HCL Able 040404 METHYLPHENIDATE HYDROCHLORIDE Tablet; 5MG METHYLPHENIDATE HCL Able 085799 METHYLPHENIDATE HYDROCHLORIDE Tablet; 10MG METHYLPHENIDATE HCL CELLTECH MFG 086428 METHYLPHENIDATE HYDROCHLORIDE Tablet; 20MG METHYLPHENIDATE HCL CELLTECH MFG 086429 METHYLPHENIDATE HYDROCHLORIDE Tablet; 5MG METHYLPHENIDATE HCL CELLTECH MFG 040300 METHYLPHENIDATE HYDROCHLORIDE Tablet; 10MG METHYLPHENIDATE HCL Mallinckrodt 040300 METHYLPHENIDATE HYDROCHLORIDE Tablet; 20MG METHYLPHENIDATE HCL Mallinckrodt 040300 METHYLPHENIDATE HYDROCHLORIDE Tablet; 5MG METHYLPHENIDATE HCL Mallinckrodt 010187 METHYLPHENIDATE HYDROCHLORIDE Tablet; 10MG RITALIN NOVARTIS 010187 METHYLPHENIDATE HYDROCHLORIDE Tablet; 20MG RITALIN NOVARTIS 010187 METHYLPHENIDATE HYDROCHLORIDE Tablet; 5MG RITALIN NOVARTIS 040321 METHYLPHENIDATE HYDROCHLORIDE Tablet; 10MG METHYLPHENIDATE HCL Purepac 040321 METHYLPHENIDATE HYDROCHLORIDE Tablet; 20MG METHYLPHENIDATE HCL Purepac 040321 METHYLPHENIDATE HYDROCHLORIDE Tablet; 5MG METHYLPHENIDATE HCL Purepac 040220 METHYLPHENIDATE HYDROCHLORIDE Tablet; 10MG METHYLPHENIDATE HCL Watson 040220 METHYLPHENIDATE HYDROCHLORIDE Tablet; 20MG METHYLPHENIDATE HCL Watson 040220 METHYLPHENIDATE HYDROCHLORIDE Tablet; 5MG METHYLPHENIDATE HCL Watson Ritalin LA (methylphenidate hydrochloride) ER Capsules, Novartis Pharmaceuticals | Concerta (methylphenidate HCL) Extended-Release Tablets, McNeil, New or Modified Indication

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