Report

reporttype1Version of Safety Report ID3receivedateformat102transmissiondateformat102fulfillexpeditecriteria1Safety Report ID10226713serious1Date Last Updated16/06/2014receiptdateformat102companynumbUS-DRREDDYS-USA/USA/14/0040957occurcountryUSseriousnessother1duplicate1Date Received10/06/2014transmissiondate12/12/2014primarysourcecountryUS

Primary Source

reportercountryUSqualification3

Patient

Onset Age15Unit of Onset AgeyearsSexMale

Contents

Reaction
- 1)
- 2)
- 3)
Drug

Reaction

1)

reactionmeddraversionpt17.0ReactionAggressionOutcomeRecovering/resolving

2)

reactionmeddraversionpt17.0ReactionIrritabilityOutcomeRecovering/resolving

3)

reactionmeddraversionpt17.0ReactionDry skinOutcomeRecovering/resolving

Drug

1)

drugcharacterization1medicinalproductZENATANEdrugbatchnumbUNKNOWN,UNKNOWN,UNKNOWNdrugauthorizationnumb202099drugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationACNEdrugstartdateformat102drugstartdate12/03/2014actiondrug2drugrecurreadministration3

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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)

drugcharacterization1medicinalproductZENATANEdrugbatchnumbUNKNOWN,UNKNOWN,UNKNOWNdrugauthorizationnumb202099drugstructuredosagenumb60drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugstartdateformat102drugstartdate09/04/2014actiondrug2drugrecurreadministration3

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3)

drugcharacterization1medicinalproductZENATANEdrugbatchnumbUNKNOWN,UNKNOWN,UNKNOWNdrugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048actiondrug2drugrecurreadministration3

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4)

drugcharacterization2medicinalproductVYVANSEdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

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Application NumberNDA021977, NDA208510Brand NameVYVANSEGeneric NameLISDEXAMFETAMINE DIMESYLATEManufacturersShire LLCproduct_ndc 59417-101, 59417-102, 59417-103, 59417-104, 59417-105, 59417-106, 59417-107, 594 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLISDEXAMFETAMINE DIMESYLATERXCUI 854830, 854832, 854834, 854836, 854838, 854840, 854842, 854844, 854846, 854848, ... spl_idd2aa8390-b739-4621-abff-bd18bf342f65spl_set_id704e4378-ca83-445c-8b45-3cfa51c1ecadPackage NDC 59417-101-10, 59417-102-10, 59417-103-10, 59417-104-10, 59417-105-10, 59417-106- ... UNIISJT761GEGS

5)

drugcharacterization2medicinalproductFLONASEdrugadministrationroute065drugindicationPRODUCT USED FOR UNKNOWN INDICATION

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Application NumberNDA205434Brand NameFLONASE ALLERGY RELIEFGeneric NameFLUTICASONE PROPIONATEManufacturersGlaxoSmithKline Consumer Healthcare Holdings (US) LLCproduct_ndc0135-0576Product TypeHUMAN OTC DRUGRouteNASALActive IngredientsFLUTICASONE PROPIONATERXCUI1797907, 1797933spl_id746e63f3-5386-4e7b-811d-8cfd3e9120d8spl_set_idb6134ba0-b70a-4eac-9a82-cef64b242c1dPackage NDC 0135-0576-01, 0135-0576-02, 0135-0576-03, 0135-0576-04, 0135-0576-12, 0135-0576- ... UNIIO2GMZ0LF5W

6)

drugcharacterization2medicinalproductHYDROCORTISONEdrugdosageformOINTMENTdrugadministrationroute061drugindicationPRODUCT USED FOR UNKNOWN INDICATION

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Application Number part348, ANDA088799, ANDA040351, ANDA089682, ANDA080706, NDA213876, ANDA040646, ... Brand Name HARRIS TEETER ANTI-ITCH WITH ALOE, DG HEALTH HYDROCORTISONE, PROCTOSOL-HC, GOOD ... Generic Name HYDROCORTISONE, ANTIPRURITIC (ANTI-ITCH), ANTI-ITCH CREAM, ANTI-ITCH, HYDROCORTI ... Manufacturers Harris Teeter, Dolgencorp, LLC, Sun Pharmaceutical Industries, Inc., Amerisource ... product_ndc 72036-407, 55910-646, 10631-407, 24385-276, 67091-280, 69396-069, 61010-4402, 70 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteTOPICAL, ORAL, RECTALActive IngredientsHYDROCORTISONE, HYDROCORTISONE ACETATERXCUI 106258, 103403, 310891, 1540356, 203105, 197785, 1790684, 206352, 1043063, 19870 ... spl_id 2b90d9a3-ebb1-4aee-8a9c-6601618b7738, 27dc9e09-fc4f-4b66-a303-177725f3a513, 297a ... spl_set_id 1755c97e-87a3-43c7-ab61-3e971a7b3135, 27dc9e09-fc4f-4b66-a303-177725f3a513, 5652 ... Package NDC 72036-407-28, 55910-646-25, 10631-407-01, 24385-276-03, 67091-280-28, 69396-069- ... NUIN0000175576, N0000175450Established Pharmacologic ClassCorticosteroid [EPC]Mechanism of ActionCorticosteroid Hormone Receptor Agonists [MoA]UNIIWI4X0X7BPJ, 3X7931PO74

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duplicatesourceDR REDDYSduplicatenumbUS-DRREDDYS-USA/USA/14/0040957

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