Report reporttype 1 receiptdateformat 102 companynumb US-TEVA-405147USA occurcountry US Version of Safety Report ID 2 receivedateformat 102 duplicate 1 transmissiondateformat 102 fulfillexpeditecriteria 2 Safety Report ID 10155283 Date Received 06/05/2014 transmissiondate 12/12/2014 serious 2 Date Last Updated 06/05/2014 primarysourcecountry US Receiver receivertype 6 receiverorganization FDA Primary Source reportercountry US qualification 1 Sender sendertype 2 senderorganization FDA-Public Use Patient Onset Age 24 Unit of Onset Age years Sex Female Reaction 1) reactionmeddraversionpt 17.0 Reaction Blood triglycerides increased Outcome Recovered/resolved Drug 1) drugcharacterization 1 medicinalproduct CLARAVIS drugauthorizationnumb 076135 drugstructuredosagenumb 30 drugstructuredosageunit 003 drugseparatedosagenumb 2 drugintervaldosageunitnumb 1 drugintervaldosagedefinition 804 drugdosagetext 60 MILLIGRAM DAILY; drugdosageform CAPSULE drugadministrationroute 048 drugstartdateformat 102 drugstartdate 12/02/2013 drugenddateformat 102 drugenddate 14/03/2013 actiondrug 1 openFDA Info on Medication Application Number ANDA076356, ANDA076135 Brand Name CLARAVIS Generic Name ISOTRETINOIN Manufacturers Teva Pharmaceuticals USA, Inc. product_ndc 0555-1054, 0555-1055, 0555-1056, 0555-1057 Product Type HUMAN PRESCRIPTION DRUG Route ORAL Active Ingredients ISOTRETINOIN RXCUI 197843, 197844, 197845, 403930, 404059, 404062, 404065, 643488 spl_id e462821c-84c4-4009-a26e-da92790126bf spl_set_id a31fd109-d0fd-4ab9-ba98-a3d64333c18d Package NDC
0555-1054-60, 0555-1054-86, 0555-1054-56, 0555-1055-60, 0555-1055-86, 0555-1055- ...
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NUI N0000175607, M0018962 Established Pharmacologic Class Retinoid [EPC] Chemical Structure Retinoids [CS] UNII EH28UP18IF Report Duplicate duplicatesource TEVA duplicatenumb US-TEVA-405147USA
