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… Comtan (Entacapone) Tablets, 200 mg, Orion NDA 20-796 Stalevo 50, 100 & 150 (carbidopa/ levodopa/ entacapone) Tablets, Orion Pharma, NDA 21-485 | Stalevo (levodopa/carbidopa/entacapone) Tablets, Orion Corporation, Formulation Revision | Stalevo (levodopa and carbidopa and entacapone) Tablets, Orion Corp., Formulation Revision | Stalevo (carbidopa and entacapone and levodopa) Tablets, Orion Corp., Labeling Revision | Stalevo (levodopa, carbidopa and entacapone) Tablets, Orion Corp., Labeling Revision | Comtan (entacapone) Tablets, Orion Corp., Labeling Revision | Stalevo (levodopa and carbidopa and entacapone) Tablets, Orion Corp., Labeling Revision | Comtan (entacapone) Tablets, Orion Corp., Labeling Revision | Stalevo (levodopa, carbidopa and entacapone) Tablets, Orion Corp., Labeling Revision | Carbidopa, Levodopa and Entacapone, carbidopa; entacapone; levodopa, Tablet; Oral, Sun Pharma Global, Approval | Entacapone, entacapone, Tablet; Oral, Sun Pharma Global, Approval | Entacapone, entacapone, Tablet; Oral, Wockhardt Ltd, Approval | Carbidopa, Levodopa and Entacapone, carbidopa; entacapone; levodopa, Tablet; Oral, Wockhardt Ltd, Tentative Approval | Carbidopa, Levodopa and Entacapone, carbidopa; entacapone; levodopa, Tablet; Oral, Wockhardt Ltd, Approval | Stalevo 100, carbidopa; entacapone; levodopa, Tablet; Oral, Orion Pharma, Manufacturing Change or Addition | Stalevo 125, carbidopa; entacapone; levodopa, Tablet; Oral, Orion Pharma, Manufacturing Change or Addition | Stalevo 150, carbidopa; entacapone; levodopa, Tablet; Oral, Orion Pharma, Manufacturing Change or Addition | Stalevo 200, carbidopa; entacapone; levodopa, Tablet; Oral, Orion Pharma, Manufacturing Change or Addition | Stalevo 50, carbidopa; entacapone; levodopa, Tablet; Oral, Orion Pharma, Manufacturing Change or Addition | Stalevo 75, carbidopa; entacapone; levodopa, Tablet; Oral, Orion Pharma, Manufacturing Change or Addition | Entacapone, entacapone, Tablet; Oral, Mylan Pharms Inc, Approval ^ 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 © 2013 Betterchem.com