Adverse Event Report

Report

reporttype1Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria2Safety Report ID11328858serious1Date Last Updated01/08/2015receiptdateformat102companynumbUS-RANBAXY-2012US-57384occurcountryUSseriousnessother1duplicate1Date Received01/08/2015transmissiondate25/11/2015primarysourcecountryUS

Primary Source

reportercountryUSqualification4

Patient

SexMale

Reaction

1)

reactionmeddraversionpt18.1ReactionInflammatory bowel diseaseOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductSOTRETdrugauthorizationnumb76503drugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

activesubstance

activesubstancenameISOTRETINOIN

2)

drugcharacterization1medicinalproductACCUTANEdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONactiondrug5drugrecurreadministration3

activesubstance

activesubstancenameISOTRETINOIN

openFDA Info on Medication

Application NumberANDA202099Brand NameACCUTANEGeneric NameISOTRETINOINManufacturersJG Pharma Inc.product_ndc72143-231, 72143-232, 72143-234, 72143-233Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsISOTRETINOINRXCUI197843, 197844, 197845, 206880, 206883, 206902, 403930, 2473107spl_ida599c5e2-aeaa-4667-b6fa-ddc56bbb71daspl_set_ida41ceb83-aaca-4f9d-ae33-c53b1ca71e41Package NDC 72143-231-10, 72143-231-30, 72143-232-10, 72143-232-30, 72143-234-10, 72143-234- ... NUIN0000175607, M0018962Established Pharmacologic ClassRetinoid [EPC]Chemical StructureRetinoids [CS]UNIIEH28UP18IF

Report Duplicate

duplicatesourceRANBAXYduplicatenumbUS-RANBAXY-2012US-57384

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use