Report reporttype 2 Version of Safety Report ID 2 receivedateformat 102 transmissiondateformat 102 fulfillexpeditecriteria 1 Safety Report ID 10051218 serious 1 Date Last Updated 29/04/2014 receiptdateformat 102 companynumb US-TEVA-472161USA occurcountry US seriousnessother 1 duplicate 1 Date Received 01/04/2014 transmissiondate 12/12/2014 primarysourcecountry US Primary Source reportercountry US qualification 1 Patient Onset Age 15 Unit of Onset Age years Sex Male Reaction 1) reactionmeddraversionpt 17.0 Reaction Suicidal ideation Outcome Recovered/resolved 2) reactionmeddraversionpt 17.0 Reaction Depression Outcome Unknown Drug 1) drugcharacterization 1 medicinalproduct CLARAVIS drugauthorizationnumb 076135 drugdosageform CAPSULE drugadministrationroute 048 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-472161USA Receiver receivertype 6 receiverorganization FDA Sender sendertype 2 senderorganization FDA-Public Use
