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"submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "submission_property_type": [ { "code": "Orphan" } ], "application_docs": [ { "id": "59366", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/204114Orig1s013ltr.pdf", "date": "20190717", "type": "Letter" }, { "id": "59368", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204114s013lbl.pdf", "date": "20190718", "type": "Label" } ] } ], "application_number": "NDA204114", "sponsor_name": "NOVARTIS", "openfda": { "application_number": [ "NDA204114" ], "brand_name": [ "MEKINIST" ], "generic_name": [ "TRAMETINIB" ], "manufacturer_name": [ "Novartis Pharmaceuticals Corporation" ], "product_ndc": [ "0078-1105", "0078-1112", "0078-1161" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "TRAMETINIB DIMETHYL SULFOXIDE" ], "rxcui": [ "1425110", "1425116", "1425118", "2632560", "2632564", "1425104" ], "spl_id": [ "235e3bc1-099b-4587-9d72-b02fcc3387d1" ], "spl_set_id": [ "0002ad27-779d-42ab-83b5-bc65453412a1" ], "package_ndc": [ "0078-1105-15", "0078-1112-15", "0078-1112-94", "0078-1161-47" ], "unii": [ "BSB9VJ5TUT" ] }, "products": [ { "product_number": "003", "reference_drug": "Yes", "brand_name": "MEKINIST", "active_ingredients": [ { "name": "TRAMETINIB DIMETHYL SULFOXIDE", "strength": "EQ 2MG" } ], "reference_standard": "Yes", "dosage_form": "TABLET", "route": "ORAL", "marketing_status": "Prescription", "te_code": "AB" }, { "product_number": "001", "reference_drug": "Yes", "brand_name": "MEKINIST", "active_ingredients": [ { "name": "TRAMETINIB DIMETHYL SULFOXIDE", "strength": "EQ 0.5MG" } ], "reference_standard": "No", "dosage_form": "TABLET", "route": "ORAL", "marketing_status": "Prescription", "te_code": "AB" }, { "product_number": "002", "reference_drug": "Yes", "brand_name": "MEKINIST", "active_ingredients": [ { "name": "TRAMETINIB DIMETHYL SULFOXIDE", "strength": "EQ 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**" } ], "reference_standard": "No", "dosage_form": "TABLET", "route": "ORAL", "marketing_status": "Discontinued" } ] } ] }