Adverse Event Report

Report

reporttype1receiptdateformat102companynumbUS-DRREDDYS-USA/USA/14/0040085occurcountryUSVersion of Safety Report ID2receivedateformat102duplicate1transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10312756Date Received18/07/2014transmissiondate26/03/2015serious2Date Last Updated18/07/2014primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age10Unit of Onset AgeyearsSexFemale

Reaction

1)

reactionmeddraversionpt17.1ReactionDrug dispensing errorOutcomeUnknown

2)

reactionmeddraversionpt17.1ReactionProduct quality issueOutcomeUnknown

3)

reactionmeddraversionpt17.1ReactionNo adverse eventOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductZENATANEdrugbatchnumbUNKNOWNdrugauthorizationnumb202099drugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosageformCAPSULEdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate30/04/2014drugenddateformat102drugenddate01/05/2014drugrecurreadministration3

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)

drugcharacterization2medicinalproductCONCERTAdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameMETHYLPHENIDATE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA021121Brand NameCONCERTAGeneric NameMETHYLPHENIDATE HYDROCHLORIDEManufacturersJanssen Pharmaceuticals, Inc.product_ndc50458-585, 50458-588, 50458-586, 50458-587Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsMETHYLPHENIDATE HYDROCHLORIDERXCUI1091155, 1091157, 1091170, 1091172, 1091185, 1091187, 1091210, 1091212spl_id83de4a92-67e6-11e9-8dc3-11c90099106dspl_set_id1a88218c-5b18-4220-8f56-526de1a276cdPackage NDC50458-585-01, 50458-588-01, 50458-586-01, 50458-587-01UNII4B3SC438HI

3)

drugcharacterization2medicinalproductPROZACdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

activesubstance

activesubstancenameFLUOXETINE HYDROCHLORIDE

openFDA Info on Medication

Application NumberNDA018936Brand NamePROZACGeneric NameFLUOXETINE HYDROCHLORIDEManufacturersDista Products Companyproduct_ndc0777-3104, 0777-3105, 0777-3107Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsFLUOXETINE HYDROCHLORIDERXCUI104849, 205535, 261287, 310384, 310385, 313989spl_idef027dfe-1ccd-4c52-ad10-c76d6834d10cspl_set_idc88f33ed-6dfb-4c5e-bc01-d8e36dd97299Package NDC0777-3104-02, 0777-3105-02, 0777-3105-07, 0777-3105-30, 0777-3107-30UNIII9W7N6B1KJ

Report Duplicate

duplicatesourceDR REDDYSduplicatenumbUS-DRREDDYS-USA/USA/14/0040085