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 Safety Information 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… Sinemet (carbidopa-levodopa) Tablets, 10/100 mg, 25/100 mg, 25/250 mg DuPont Company NDA 17-555/S-036,S-037,S-038, S-039,S-040,S-045,S-050,S-051 | NDA 17-555/S-055 Stalevo 50, 100 & 150 (carbidopa/ levodopa/ entacapone) Tablets, Orion Pharma, NDA 21-485 Carbidopa-Levodopa Extended-release Tablets, Impax Laboratories, Inc. Carbidopa/Levodopa Extended-release Tablets, TorPharm, Inc. Carbidopa and Levodopa Extended-release Tablets, KV Pharmaceutical Carbidopa/Levodopa Orally Disintegrating Tabs, Schwarz Pharma, Approval | Carbilev (Carbidopa/Levodopa) Tablets, Ranbaxy, Approval | Levodopa Tablets, Actavis, Control Supplement | Stalevo (levodopa/carbidopa/entacapone) Tablets, Orion Corporation, Formulation Revision | Carbidopa and Levodopa Extended Release Tablets, Sun Pharma, Approval | Carbidopa and Levodopa Tablets, Apotex Corp., Approval | Stalevo (levodopa and carbidopa and entacapone) Tablets, Orion Corp., Formulation Revision | Carbidopa and Levodopa Orally Disintegrating Tablets, Mylan Pharmaceuticals, Inc., Approval | Stalevo (carbidopa and entacapone and levodopa) Tablets, Orion Corp., Labeling Revision | Stalevo (levodopa, carbidopa and entacapone) Tablets, Orion Corp., Labeling Revision | Carbidopa and Levodopa Tablets, Sun Pharmaceutical Industries Ltd., Approval | Sinemet (carbidopa and levodopa) Tablets, Bristol-Myers Squibb Co., Labeling Revision | Sinemet CR (carbidopa and levodopa) Extended-ReleaseTablets, Bristol-Myers Squibb Co., Labeling Revision | Stalevo (levodopa and carbidopa and entacapone) Tablets, Orion Corp., Labeling Revision | Carbidopa and Levodopa Tablets, Mylan Pharmaceuticals, Inc., Approval | Carbidopa and Levodopa Orally Disintegrating Tablets, Impax Laboratories, Inc., Approval | Stalevo (levodopa, carbidopa and entacapone) Tablets, Orion Corp., Labeling Revision | Sinemet (carbidopa and levodopa) Tablets, Merck Sharp & Dohme Corp., Manufacturing Change or Addition | Sinemet CR (carbidopa and levodopa) Extended-Release Tablets, Merck Sharp & Dohme Corp., Manufacturing Change or Addition ^ 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 | For Industry | DMF Index | Pharma Job Search | Pharma Company News | Best Phone © 2012 Betterchem.com