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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 | Metadate CD (Methylphenidate HCL) Extended-Release Capsules, UCB Pharma, Control Supplement | Daytrana (methylphenidate) Transdermal System,Noven Pharma, Approval | Daytrana (methylphenidate transdermal system), Shire Pharma, Labeling Revision | Ritalin (methylphenidate hydrochloride) Tablets, Novartis Pharma, Labeling Revision | Ritalin SR (methylphenidate hydrochloride) Sustained-Release, Novartis Pharma, Labeling Revision | Ritalin LA (methylphenidate hydrochloride) Extended-Release Capsules, Novartis Pharma, Labeling Revision | Metadate CD (methylphenidate hydrochloride) Extended-Release Capsules, UCB Pharma, Labeling Revision | Methylin (methylphenidate hydrochloride) Chewable Tablets, Tyco Healthcare, Labeling Revision | Methylin (methylphenidate hydrochloride) Oral Solution, Tyco Healthcare, Labeling Revision | Concerta (methylphenidate hydrochloride) Extended-Release Tablets, McNeil Consumer, Labeling Revision | Ritalin (methylphenidate HCl) Tablets, Novartis Pharma, Labeling Revision | Ritalin SR (methylphenidate HCl) Sustained Release Tablets, Novartis Pharma, Labeling Revision | Ritalin LA (methylphenidate HCl) Extended Release Capsules, Novartis Pharma, Labeling Revision | Daytrana (methylphenidate) Transdermal System, Noven Pharma, Labeling Revision | Concerta (methylphenidate hydrochloride) Extended-Release Tablets, Johnson & Johnson, Labeling Revision | Metadate CD (methylphenidate HCl) Extended-Release Capsules, UCB Inc., Labeling Revision | Methylin (methylphenidate) Oral Solution, Mallinckrodt, Labeling Revision | Methylin (methylphenidate) Chewable Tablets, Mallinckrodt, Labeling Revision | Daytrana (methylphenidate) Transdermal System, Shire Development, Labeling Revision | Concerta (methylphenidate hydrochloride) Extended-Release Tablets, Alza Corp., Labeling Revision | Concerta (methylphenidate hydrochloride) Extended-Release Tablets, Alza Corp., Patient Population Altered | Metadate CD (methylphenidate hydrochloride) Extended-Release Capsules, UCB, Inc., Labeling Revision | Metadate CD (methylphenidate hydrochloride) Extended-Release Capsules, UCB, Inc., Labeling Revision | Concerta (methylphenidate hydrochloride) Extended-Release Tablets, Johnson & Johnson Pharmaceutical Research & Development, Efficacy Supp. w/Clinical Data | Daytrana (methylphenidate) Patch,Shire Development, Inc., Labeling Revision | Ritalin LA (methylphenidate hydrochloride) Extended-Release Capsules, Novartis Pharmaceuticals Corp., Labeling Revision | Daytrana (methylphenidate) Patch, Shire Pharmaceuticals, Labeling Revision | Daytrana (methylphenidate) Patch, Shire Pharmaceuticals, New or Modified Indication | Methylphenidate Hydrochloride Oral Solution, Tris Pharma, Inc., Approval | Daytrana (methylphenidate) Film, Noven Pharmaceuticals, Inc., Labeling Revision | Metadate CD (methylphenidate hydrochloride) Extended-Release Capsules, UCB Inc., Labeling Revision | Methylin (methylphenidate hydrochloride) Chewable Tablets, Mallinckrodt Inc., Labeling Revision | Methylin (methylphenidate) Oral Solution, Mallinckrodt Inc., Labeling Revision | Ritalin (methylphenidate hydrochloride) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision | Ritalin-SR (methylphenidate hydrochloride) Extended-Release Tablets, Novartis Pharmaceuticals Corp., Labeling Revision | Ritalin LA (methylphenidate hydrochloride) Extended-Release Capsules, Novartis Pharmaceuticals Corp., Labeling Revision | Concerta (methylphenidated hydrochloride) Extended-Release Tablets, Johnson & Johnson Pharmaceutical Research & Development, LLC, Labeling Revision | Ritalin (methylphenidate hydrochloride) Tablets, Novartis Pharmaceuticals, Labeling Revision | Ritalin LA (methylphenidate hydrochloride) Extended-Release Capsules, Novartis Pharmaceuticals, Labeling Revision | Ritalin SR (methylphenidate hydrochloride) Extended-Release Tablets, Novartis Pharmaceuticals, Labeling Revision | Methylphenidate Hydrochloride Extended-Release Capsules, Actavis South Atlantic, LLC, Approval | Methylphenidate Hydrochloride Extended-Release Capsules, Actavis, Approval
  
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