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FDA Approval Activities for this Drug…
Carbidopa and Levodopa Extended-release tablets, 50 mg/200 mg Mylan ANDA 75-091 Sinemet (carbidopa-levodopa) Tablets, 10/100 mg, 25/100 mg, 25/250 mg DuPont Company NDA17-555/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 Tablet; 25MG LODOSYN BRISTOL MYERS SQUIBB | 021485 CARBIDOPA; ENTACAPONE; LEVODOPA Tablet; 12.5MG;200MG;50MG STALEVO 50 ORION INC | 021485 CARBIDOPA; ENTACAPONE; LEVODOPA Tablet; 25MG;200MG;100MG STALEVO 100 ORION INC | 021485 CARBIDOPA; ENTACAPONE; LEVODOPA Tablet; 37.5MG;200MG;150MG STALEVO 150 ORION INC | 019856 CARBIDOPA; LEVODOPA Tablet, Extended Release; 25MG;100MG SINEMET CR BRISTOL MYERS SQUIBB | 019856 CARBIDOPA; LEVODOPA Tablet, Extended Release; 50MG;200MG SINEMET CR BRISTOL MYERS SQUIBB | 075091 CARBIDOPA; LEVODOPA Tablet, Extended Release; 25MG;100MG CARBIDOPA AND LEVODOPA Mylan | 075091 CARBIDOPA; LEVODOPA Tablet, Extended Release; 50MG;200MG CARBIDOPA AND LEVODOPA Mylan | 017555 CARBIDOPA; LEVODOPA Tablet; 10MG;100MG SINEMET BRISTOL MYERS SQUIBB | 017555 CARBIDOPA; LEVODOPA Tablet; 25MG;100MG SINEMET BRISTOL MYERS SQUIBB | 017555 CARBIDOPA; LEVODOPA Tablet; 25MG;250MG SINEMET BRISTOL MYERS SQUIBB | 073586 CARBIDOPA; LEVODOPA Tablet; 10MG;100MG CARBIDOPA AND LEVODOPA Geneva | 073587 CARBIDOPA; LEVODOPA Tablet; 25MG;100MG CARBIDOPA AND LEVODOPA Geneva | 073620 CARBIDOPA; LEVODOPA Tablet; 25MG;250MG CARBIDOPA AND LEVODOPA Geneva | 074260 CARBIDOPA; LEVODOPA Tablet; 10MG;100MG CARBIDOPA AND LEVODOPA Purepac | 074260 CARBIDOPA; LEVODOPA Tablet; 25MG;100MG CARBIDOPA AND LEVODOPA Purepac | 074260 CARBIDOPA; LEVODOPA Tablet; 25MG;250MG CARBIDOPA AND LEVODOPA Purepac 073618 CARBIDOPA; LEVODOPA Tablet; 10MG;100MG CARBIDOPA AND LEVODOPA Teva 073589 CARBIDOPA; LEVODOPA Tablet; 25MG;100MG CARBIDOPA AND LEVODOPA Teva 073607 CARBIDOPA; LEVODOPA Tablet; 25MG;250MG CARBIDOPA AND LEVODOPA Teva 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 | 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 | Carbidopa, Levodopa and Entacapone Tablets, Sun Pharmaceutical, Tentative 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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