Key Data Files for this Active Pharmaceutical Ingredient:

Drug Master Files, 21 CFR, and other industry portals Patent/Exclusivity data file Drug Approval Drug Safety Freedom of Information Federal Register pages Pharma Companies Pharmacopeial Information Preferred API Supplier (Clients Only)

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   For the latest approval information, locate this drug using this index.