Adverse Event Report

Report

reporttype1receiptdateformat102companynumbUS-DRREDDYS-USA/USA/14/0041341occurcountryUSVersion of Safety Report ID2receivedateformat102duplicate1transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10313123Date Received18/07/2014transmissiondate28/05/2015serious2Date Last Updated20/10/2014primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification3

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age32Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt18.0ReactionDrug ineffectiveOutcomeUnknown

2)

reactionmeddraversionpt18.0ReactionPhotosensitivity reactionOutcomeNot recovered/not resolved

3)

reactionmeddraversionpt18.0ReactionProduct quality issueOutcomeUnknown

4)

reactionmeddraversionpt18.0ReactionSkin hyperpigmentationOutcomeUnknown

5)

reactionmeddraversionpt18.0ReactionPruritusOutcomeNot recovered/not resolved

Drug

1)

drugcharacterization1medicinalproductZENATANEdrugbatchnumbYW4066drugauthorizationnumb202099drugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationACNEdrugstartdateformat102drugstartdate27/05/2014actiondrug4

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

2)

drugcharacterization2medicinalproductTRI-SPRINTECdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameETHINYL ESTRADIOL\NORGESTIMATE

openFDA Info on Medication

Application NumberANDA075808Brand NameTRI-SPRINTECGeneric NameNORGESTIMATE AND ETHINYL ESTRADIOLManufacturersTeva Pharmaceuticals USA, Inc.product_ndc0555-9018Product TypeHUMAN PRESCRIPTION DRUGRXCUI240128, 406396, 687424, 748797, 749784, 762333spl_id4410ea34-8a24-4316-8658-431a13e02e46spl_set_id843cbef6-cbfb-4a44-bb80-22930753e4c0Package NDC0555-9018-58

summary

narrativeincludeclinicalCASE EVENT DATE: 20140615

Report Duplicate

duplicatesourceDR REDDYSduplicatenumbUS-DRREDDYS-USA/USA/14/0041341