Report reporttype 1 receiptdateformat 102 companynumb 2014VERF00026 Version of Safety Report ID 1 receivedateformat 102 seriousnessother 1 duplicate 1 transmissiondateformat 102 fulfillexpeditecriteria 1 Safety Report ID 10258268 Date Received 23/06/2014 transmissiondate 12/12/2014 serious 1 Date Last Updated 23/06/2014 primarysourcecountry US Receiver receivertype 6 receiverorganization FDA Primary Source reportercountry US qualification 3 Sender sendertype 2 senderorganization FDA-Public Use Patient Onset Age 17 Unit of Onset Age years Sex Female Reaction 1) reactionmeddraversionpt 17.0 Reaction Depression 2) reactionmeddraversionpt 17.0 Reaction Anger Drug 1) drugcharacterization 1 medicinalproduct MYORISAN drugauthorizationnumb 076485 openFDA Info on Medication Application Number ANDA076485 Brand Name MYORISAN Generic Name ISOTRETINOIN Manufacturers Versapharm Incorporated product_ndc 61748-301, 61748-302, 61748-303, 61748-304 Product Type HUMAN PRESCRIPTION DRUG Route ORAL Active Ingredients ISOTRETINOIN RXCUI 197843, 197844, 197845, 403930, 1242611, 1242613, 1242615, 1663728 spl_id 703dd363-236a-4a17-85e9-feb1b3ae540b spl_set_id 51ff6346-9256-4c01-9f52-417d13f2df05 Package NDC
61748-301-13, 61748-301-11, 61748-301-01, 61748-302-13, 61748-302-11, 61748-302- ...
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NUI N0000175607, M0018962 Established Pharmacologic Class Retinoid [EPC] Chemical Structure Retinoids [CS] UNII EH28UP18IF Report Duplicate duplicatesource VERSAPHARM duplicatenumb 2014VERF00026
