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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
  
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