Adverse Event Report

Report

reporttype1receiptdateformat102companynumb2014VER00229Version of Safety Report ID3receivedateformat102seriousnessother1duplicate1transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10522440Date Received10/10/2014transmissiondate20/07/2015serious1Date Last Updated09/03/2015primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification3

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age19Unit of Onset AgeyearsWeight49.9SexFemale

Reaction

1)

reactionmeddraversionpt18.0ReactionConcomitant disease progression

2)

reactionmeddraversionpt18.0ReactionCondition aggravated

3)

reactionmeddraversionpt18.0ReactionDepression

Drug

1)

drugcharacterization1medicinalproductMYORISANdrugauthorizationnumb076485drugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugindicationACNE CYSTICdrugstartdateformat102drugstartdate23/05/2014drugenddateformat102drugenddate22/07/2014drugadditional1

activesubstance

activesubstancenameISOTRETINOIN

openFDA Info on Medication

Application NumberANDA076485Brand NameMYORISANGeneric NameISOTRETINOINManufacturersVersapharm Incorporatedproduct_ndc61748-301, 61748-302, 61748-303, 61748-304Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsISOTRETINOINRXCUI197843, 197844, 197845, 403930, 1242611, 1242613, 1242615, 1663728spl_id703dd363-236a-4a17-85e9-feb1b3ae540bspl_set_id51ff6346-9256-4c01-9f52-417d13f2df05Package NDC 61748-301-13, 61748-301-11, 61748-301-01, 61748-302-13, 61748-302-11, 61748-302- ... NUIN0000175607, M0018962Established Pharmacologic ClassRetinoid [EPC]Chemical StructureRetinoids [CS]UNIIEH28UP18IF

2)

drugcharacterization2medicinalproductSERTRALINE

activesubstance

activesubstancenameSERTRALINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberANDA077670, ANDA077864, ANDA077397Brand NameSERTRALINEGeneric NameSERTRALINE, SERTRALINE HYDROCHLORIDEManufacturers Lupin Pharmaceuticals, Inc., Hikma Pharmaceuticals USA Inc., Exelan Pharmaceutic ... product_ndc 68180-351, 68180-352, 68180-353, 0143-9655, 0143-9656, 0143-9654, 76282-212, 762 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsSERTRALINE HYDROCHLORIDERXCUI312938, 312940, 312941spl_id 78d3579a-260f-4bb2-95f2-8ee8a60fae18, f35de481-61af-428e-abb4-a267238b3959, 5c8d ... spl_set_id 42120ff8-b353-4632-9ea9-54de9a698724, f9641190-9151-4f7e-89ff-1e7a818c30ee, 2dac ... Package NDC 68180-351-06, 68180-351-08, 68180-351-09, 68180-351-01, 68180-351-03, 68180-352- ... UNIIUTI8907Y6X

3)

drugcharacterization2medicinalproductJOLESSA

activesubstance

activesubstancenameETHINYL ESTRADIOL\LEVONORGESTREL

openFDA Info on Medication

Application NumberNDA021544Brand NameJOLESSAGeneric NameLEVONORGESTREL / ETHINYL ESTRADIOLManufacturersTeva Pharmaceuticals USA, Inc.product_ndc0555-9123Product TypeHUMAN PRESCRIPTION DRUGRXCUI238019, 748797, 751901, 762663spl_id28f8309d-d1cb-40b7-ac5a-a557a7150cc7spl_set_idf1076019-6f2c-4c90-9f3c-ab0c7cdd9315Package NDC0555-9123-66

summary

narrativeincludeclinicalCASE EVENT DATE: 2014

Report Duplicate

duplicatesourceVERSAPHARMduplicatenumb2014VER00229