Adverse Event Report

Report

reporttype1Version of Safety Report ID2receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10261047serious1Date Last Updated02/07/2014receiptdateformat102companynumbUS-DRREDDYS-USA/USA/14/0041311occurcountryUSseriousnessother1duplicate1Date Received26/06/2014transmissiondate26/03/2015primarysourcecountryUS

Primary Source

reportercountryUSqualification1

Patient

Onset Age18Unit of Onset AgeyearsWeight65.7SexMale

Reaction

1)

reactionmeddraversionpt17.1ReactionHypersomniaOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt17.1ReactionDepressed moodOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt17.1ReactionFatigueOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization1medicinalproductZENATANEdrugbatchnumbAYW343drugauthorizationnumb202099drugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformCAPSULEdrugadministrationroute048drugindicationACNEdrugstartdateformat102drugstartdate06/06/2014drugenddateformat102drugenddate15/06/2014actiondrug1drugrecurreadministration3

activesubstance

activesubstancenameISOTRETINOIN

openFDA Info on Medication

Application NumberANDA202099Brand NameZENATANEGeneric NameISOTRETINOINManufacturersDr. Reddy's Laboratories Limitedproduct_ndc55111-113, 55111-135, 55111-136, 55111-137Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsISOTRETINOINRXCUI197843, 197844, 197845, 403930, 1373333, 1373335, 1373337, 1605088spl_id1f5178c1-0f6f-824d-d0ee-1b973377ccc6spl_set_id27b3cf26-f22e-5b70-1c24-009933b7c6eePackage NDC 55111-135-79, 55111-135-81, 55111-136-79, 55111-136-81, 55111-137-79, 55111-137- ... NUIN0000175607, M0018962Established Pharmacologic ClassRetinoid [EPC]Chemical StructureRetinoids [CS]UNIIEH28UP18IF

Report Duplicate

duplicatesourceDR REDDYSduplicatenumbUS-DRREDDYS-USA/USA/14/0041311

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use