Adverse Event Report

Report

reporttype3Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10052263serious1Date Last Updated02/04/2014receiptdateformat102companynumbDE-LUPIN PHARMACEUTICALS INC.-E2B_00001867occurcountryDEseriousnessother1duplicate1seriousnesscongenitalanomali1Date Received02/04/2014seriousnesshospitalization1transmissiondate12/12/2014primarysourcecountryDE

Primary Source

reportercountryDE

Patient

Onset Age1Unit of Onset AgedaysWeight4.26SexMale

Reaction

1)

reactionmeddraversionpt17.0ReactionNeonatal respiratory distress syndromeOutcomeRecovered/resolved

2)

reactionmeddraversionpt17.0ReactionKidney duplexOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt17.0ReactionFoetal exposure during pregnancyOutcomeUnknown

4)

reactionmeddraversionpt17.0ReactionFoetal macrosomiaOutcomeUnknown

5)

reactionmeddraversionpt17.0ReactionUrinary tract infectionOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductSERTRALINEdrugbatchnumbUNKNOWNdrugauthorizationnumb077670drugadministrationroute064drugindicationANXIETY DISORDERdrugstartdateformat102drugstartdate20/01/2012drugenddateformat102drugenddate15/10/2012

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

2)

drugcharacterization1medicinalproductZOPICLONEdrugbatchnumbUNKNOWNdrugstructuredosagenumb7.5drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute064drugindicationSLEEP DISORDERdrugstartdateformat102drugstartdate20/01/2012

3)

drugcharacterization1medicinalproductOPIPRAMOLdrugbatchnumbUNKNOWNdrugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute064drugindicationDEPRESSIONdrugstartdateformat102drugstartdate20/01/2012

4)

drugcharacterization2medicinalproductCENTRUM MATERNAdrugstructuredosagenumb.4drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute064drugindicationPROPHYLAXIS OF NEURAL TUBE DEFECTdrugstartdateformat102drugstartdate02/03/2012drugenddateformat102drugenddate15/10/2012

5)

drugcharacterization2medicinalproduct(NASENTROPFEN Kdrugadministrationroute064drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate20/01/2012drugenddateformat102drugenddate15/10/2012

Report Duplicate

duplicatesourceLUPINduplicatenumbDE-LUPIN PHARMACEUTICALS INC.-E2B_00001867

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use