Adverse Event Report

Report

reporttype1Version of Safety Report ID1receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10196736serious1Date Last Updated27/05/2014receiptdateformat102companynumbUS-DRREDDYS-USA/USA/14/0040630occurcountryUSseriousnessother1duplicate1Date Received27/05/2014seriousnesshospitalization1transmissiondate12/12/2014primarysourcecountryUS

Primary Source

reportercountryUSqualification5

Patient

Onset Age16Unit of Onset AgeyearsWeight61.2SexFemale

Reaction

1)

reactionmeddraversionpt17.0ReactionAffect labilityOutcomeRecovering/resolving

2)

reactionmeddraversionpt17.0ReactionAnxietyOutcomeRecovering/resolving

3)

reactionmeddraversionpt17.0ReactionDepressionOutcomeRecovering/resolving

4)

reactionmeddraversionpt17.0ReactionSuicidal ideationOutcomeRecovering/resolving

Drug

1)

drugcharacterization1medicinalproductZENATANEdrugbatchnumbUNKNOWNdrugauthorizationnumb202099drugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformCAPSULEdrugadministrationroute048drugindicationACNE CYSTICdrugstartdateformat102drugstartdate28/02/2014drugenddateformat610drugenddate/05/2014actiondrug1drugrecurreadministration3

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)

drugcharacterization2medicinalproductSINGULAIRdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application NumberNDA020829, NDA020830, NDA021409Brand NameSINGULAIRGeneric NameMONTELUKAST SODIUMManufacturersMerck Sharp & Dohme Corp.product_ndc0006-9117, 0006-3841, 0006-1711, 0006-9275Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMONTELUKAST SODIUMRXCUI153892, 153893, 200224, 242438, 261367, 311759, 351246, 404406spl_id96717981-6ea2-4720-a749-e14f1559511fspl_set_id8c166755-7711-4df9-d689-8836a1a70885Package NDC 0006-3841-30, 0006-3841-14, 0006-1711-31, 0006-1711-54, 0006-9275-31, 0006-9275- ... UNIIU1O3J18SFL

3)

drugcharacterization2medicinalproductPROAIRdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application NumberNDA021457Brand NamePROAIR HFAGeneric NameALBUTEROL SULFATEManufacturersTeva Respiratory, LLCproduct_ndc59310-579Product TypeHUMAN PRESCRIPTION DRUGRouteRESPIRATORY (INHALATION)Active IngredientsALBUTEROL SULFATERXCUI745752, 2123072spl_id07738d64-2ab5-4f96-bce1-f92bbb93ef18spl_set_id8e701d71-1dcb-4b84-bada-84e4f04f5e62Package NDC59310-579-22, 59310-579-23UNII021SEF3731

4)

drugcharacterization2medicinalproductALLEGRAdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

5)

drugcharacterization2medicinalproductRECLIPSENdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

openFDA Info on Medication

Application NumberANDA075256Brand NameRECLIPSEN 28 DAYGeneric NameDESOGESTREL AND ETHINYL ESTRADIOLManufacturersTeva Pharmaceuticals USA, Inc.product_ndc0093-3304Product TypeHUMAN PRESCRIPTION DRUGRXCUI240707, 748797, 749848, 753543spl_id65e7cce0-ecf5-438e-945a-06f658771f2espl_set_ida1e00bc6-7487-4057-9dcc-d0e2327d1d12Package NDC0093-3304-28, 0093-3304-16

Report Duplicate

duplicatesourceDR REDDYSduplicatenumbUS-DRREDDYS-USA/USA/14/0040630

Receiver

receivertype6receiverorganizationFDA

Sender

sendertype2senderorganizationFDA-Public Use