Report

Version of Safety Report ID6Safety Report ID10452203primarysourcecountryJPoccurcountryJPtransmissiondateformat102transmissiondate25/05/2016reporttype2serious1seriousnessother1receivedateformat102Date Received15/09/2014receiptdateformat102Date Last Updated09/02/2016fulfillexpeditecriteria1companynumbPHHY2013JP091125duplicate1

Report Duplicate

duplicatesourceNOVARTISduplicatenumbPHHY2013JP091125

Primary Source

reportercountryJPqualification2

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age24Unit of Onset AgeyearsSexMale

Contents

Reaction
- 1)
- 2)
- 3)
- 4)
- 5)
- 6)
- 7)
- 8)
- 9)
- 10)
- 11)
- 12)
- 13)
- 14)
- 15)
Drug
summary

Reaction

1)

reactionmeddraversionpt19.0ReactionWeight increasedOutcomeNot recovered/not resolved

2)

reactionmeddraversionpt19.0ReactionLeukocytosisOutcomeRecovered/resolved

3)

reactionmeddraversionpt19.0ReactionHaemoglobin decreasedOutcomeRecovered/resolved

4)

reactionmeddraversionpt19.0ReactionThirstOutcomeNot recovered/not resolved

5)

reactionmeddraversionpt19.0ReactionNeutrophil count decreasedOutcomeRecovered/resolved

6)

reactionmeddraversionpt19.0ReactionMonocytosisOutcomeRecovered/resolved

7)

reactionmeddraversionpt19.0ReactionTremorOutcomeRecovering/resolving

8)

reactionmeddraversionpt19.0ReactionHyperglycaemiaOutcomeRecovered/resolved

9)

reactionmeddraversionpt19.0ReactionSalivary hypersecretionOutcomeRecovering/resolving

10)

reactionmeddraversionpt19.0ReactionWhite blood cell count increasedOutcomeRecovered/resolved

11)

reactionmeddraversionpt19.0ReactionExtrapyramidal disorderOutcomeRecovering/resolving

12)

reactionmeddraversionpt19.0ReactionSomnolenceOutcomeNot recovered/not resolved

13)

reactionmeddraversionpt19.0ReactionLymphocyte percentage increasedOutcomeRecovered/resolved

14)

reactionmeddraversionpt19.0ReactionPolydipsiaOutcomeRecovering/resolving

15)

reactionmeddraversionpt19.0ReactionNeutrophil percentage decreasedOutcomeRecovered/resolved

Drug

1)

drugcharacterization1medicinalproductCLOZARILdrugauthorizationnumb019758drugstructuredosagenumb75drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb12drugcumulativedosageunit003drugdosagetext75 MG, QDdrugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate17/01/2013drugenddateformat102drugenddate18/01/2013actiondrug2

activesubstance

activesubstancenameCLOZAPINE

openFDA Info on Medication

Application NumberNDA019758Brand NameCLOZARILGeneric NameCLOZAPINEManufacturersHLS Therapeutics (USA), Inc.product_ndc69809-0126, 69809-0127, 69809-0130, 69809-0135Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCLOZAPINERXCUI104775, 104776, 197535, 197536, 309374, 429212, 2269079, 2269081spl_id29feed9f-c971-4c63-bcfc-0776c12215cfspl_set_id90876802-0e3a-44c9-9ff7-1754dfbe736aPackage NDC69809-0126-5, 69809-0127-5, 69809-0130-5, 69809-0135-5NUIN0000175430Established Pharmacologic ClassAtypical Antipsychotic [EPC]UNIIJ60AR2IKIC

2)

drugcharacterization1medicinalproductCLOZARILdrugauthorizationnumb019758drugstructuredosagenumb200drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb12drugcumulativedosageunit003drugdosagetext200 MG, QDdrugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate30/01/2013drugenddateformat102drugenddate21/02/2013actiondrug2

activesubstance

activesubstancenameCLOZAPINE

openFDA Info on Medication

3)

drugcharacterization1medicinalproductCLOZARILdrugauthorizationnumb019758drugstructuredosagenumb350drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb12drugcumulativedosageunit003drugdosagetext350 MG, QDdrugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate11/01/2014drugenddateformat102drugenddate07/08/2014actiondrug2

activesubstance

activesubstancenameCLOZAPINE

openFDA Info on Medication

4)

drugcharacterization1medicinalproductQUAZEPAM.drugstructuredosagenumb30drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb330drugcumulativedosageunit003drugdosagetext30 MG, QDdrugdosageformTABLETdrugadministrationroute048drugindicationSCHIZOPHRENIAdrugstartdateformat102drugstartdate28/01/2013drugenddateformat102drugenddate20/11/2013actiondrug1

activesubstance

activesubstancenameQUAZEPAM

openFDA Info on Medication

Application NumberNDA018708Brand NameQUAZEPAM, DORALGeneric NameQUAZEPAMManufacturersAtland Pharmaceuticals, LLC, Galt Pharmaceuticals, LLCproduct_ndc71993-265, 61825-165Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsQUAZEPAMRXCUI198183, 207889spl_idbaff9baa-f149-c7e9-e053-2995a90a4306, ba9a5b9e-7a98-5de2-e053-2995a90a43b9spl_set_idf7d63f3f-5303-48ab-bce2-35fd62c45799, 9727e8b4-14f1-451d-9630-84eabc772e42Package NDC71993-265-30, 71993-265-10, 61825-165-10, 61825-165-30NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNIIJF8V0828ZI

5)

drugcharacterization2medicinalproductCLONAZEPAM.drugstructuredosagenumb2drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext2 MG, QDdrugadministrationroute048drugindicationSCHIZOPHRENIAactiondrug4

activesubstance

activesubstancenameCLONAZEPAM

openFDA Info on Medication

Application Number ANDA077194, ANDA077171, ANDA074569, ANDA077147, ANDA211033, ANDA077856, NDA01753 ... Brand NameCLONAZEPAM, KLONOPINGeneric NameCLONAZEPAMManufacturers Teva Pharmaceuticals USA, Inc., Par Pharmaceutical, Inc., Accord Healthcare Inc. ... product_ndc 0093-9290, 0093-9291, 0093-9292, 0093-9293, 0093-9294, 49884-306, 49884-307, 498 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsCLONAZEPAMRXCUI 349194, 349195, 349196, 349197, 349198, 197527, 197528, 197529, 206157, 206159, ... spl_id 0a290597-0942-4e2e-bcf7-7486bf8b933e, a95f8799-0bb3-41d6-aa27-8a291127ad54, e7a6 ... spl_set_id cb2e209e-e69b-422b-8abb-34df2bc92caa, 1aef0069-80ea-483d-ac70-c8d485462c5b, 8069 ... Package NDC 0093-9290-67, 0093-9291-67, 0093-9292-67, 0093-9293-67, 0093-9294-67, 49884-306- ... NUIN0000175694, M0002356Established Pharmacologic ClassBenzodiazepine [EPC]Chemical StructureBenzodiazepines [CS]UNII5PE9FDE8GB

6)

drugcharacterization2medicinalproductHORIZONdrugstructuredosagenumb10drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext10 MG, QDdrugadministrationroute048drugstartdateformat102drugstartdate28/02/2014drugenddateformat102drugenddate20/03/2014actiondrug1

activesubstance

activesubstancenameDIAZEPAM

7)

drugcharacterization1medicinalproductCLOZARILdrugauthorizationnumb019758drugstructuredosagenumb225drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb12drugcumulativedosageunit003drugdosagetext225 MG, QDdrugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate07/01/2015actiondrug2

activesubstance

activesubstancenameCLOZAPINE

openFDA Info on Medication

8)

drugcharacterization1medicinalproductLIMASdrugstructuredosagenumb900drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext900 MG, QDdrugdosageformTABLETdrugadministrationroute048drugindicationSCHIZOPHRENIAdrugstartdateformat102drugstartdate08/02/2013drugenddateformat102drugenddate13/06/2013actiondrug4

activesubstance

activesubstancenameLITHIUM CARBONATE

9)

drugcharacterization2medicinalproductLENDORMIN DAINIPPOdrugstructuredosagenumb.25drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext0.25 MG, QDdrugdosageformTABLETdrugadministrationroute048drugindicationSCHIZOPHRENIAdrugstartdateformat102drugstartdate12/04/2013drugenddateformat102drugenddate04/09/2013actiondrug1

activesubstance

activesubstancenameBROTIZOLAM

10)

drugcharacterization2medicinalproductLUNESTAdrugstructuredosagenumb1drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 MG, QDdrugdosageformTABLETdrugadministrationroute048drugindicationSCHIZOPHRENIAdrugstartdateformat102drugstartdate13/05/2013drugenddateformat102drugenddate04/09/2013actiondrug1

activesubstance

activesubstancenameESZOPICLONE

openFDA Info on Medication

Application NumberNDA021476Brand NameLUNESTAGeneric NameESZOPICLONEManufacturersSunovion Pharmaceuticals Inc.product_ndc63402-190, 63402-191, 63402-193Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsESZOPICLONERXCUI485440, 485442, 485465, 540407, 540409, 540411spl_id4c2704d7-3027-4240-9073-3f0b24cf15b5spl_set_idfd047b2b-05a6-4d99-95cb-955f14bf329fPackage NDC 63402-190-30, 63402-191-03, 63402-191-10, 63402-191-01, 63402-191-30, 63402-193- ... UNIIUZX80K71OE

11)

drugcharacterization2medicinalproductLEXOTANdrugstructuredosagenumb5drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext5 MG, QDdrugadministrationroute048drugindicationSCHIZOPHRENIAdrugstartdateformat102drugstartdate02/09/2014actiondrug4

activesubstance

activesubstancenameBROMAZEPAM

12)

drugcharacterization2medicinalproductDEPASdrugstructuredosagenumb2drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext2 MG, QDdrugadministrationroute048drugstartdateformat102drugstartdate04/04/2014drugenddateformat102drugenddate01/09/2014actiondrug1

activesubstance

activesubstancenameETIZOLAM

13)

drugcharacterization1medicinalproductCLOZARILdrugauthorizationnumb019758drugstructuredosagenumb300drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb12drugcumulativedosageunit003drugdosagetext300 MG, QDdrugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate26/03/2013drugenddateformat102drugenddate18/04/2013actiondrug2

activesubstance

activesubstancenameCLOZAPINE

openFDA Info on Medication

14)

drugcharacterization1medicinalproductCLOZARILdrugauthorizationnumb019758drugstructuredosagenumb350drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb12drugcumulativedosageunit003drugdosagetext350 MG, QDdrugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate22/10/2014drugenddateformat102drugenddate04/11/2014actiondrug2

activesubstance

activesubstancenameCLOZAPINE

openFDA Info on Medication

15)

drugcharacterization1medicinalproductCLOZARILdrugauthorizationnumb019758drugstructuredosagenumb325drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb12drugcumulativedosageunit003drugdosagetext325 MG, QDdrugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate05/11/2014drugenddateformat102drugenddate18/11/2014actiondrug2

activesubstance

activesubstancenameCLOZAPINE

openFDA Info on Medication

16)

drugcharacterization1medicinalproductCLOZARILdrugauthorizationnumb019758drugstructuredosagenumb250drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb12drugcumulativedosageunit003drugdosagetext250 MG, QDdrugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate25/12/2014drugenddateformat102drugenddate06/01/2015actiondrug2

activesubstance

activesubstancenameCLOZAPINE

openFDA Info on Medication

17)

drugcharacterization1medicinalproductLIMASdrugstructuredosagenumb800drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext800 MG, QDdrugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate14/06/2013drugenddateformat102drugenddate04/07/2013actiondrug4

activesubstance

activesubstancenameLITHIUM CARBONATE

18)

drugcharacterization1medicinalproductLEUCON /00300201/drugindicationPROPHYLAXISactiondrug4

activesubstance

activesubstancenameADENINE

19)

drugcharacterization2medicinalproductFLUNITRAZEPAMdrugstructuredosagenumb2drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext2 MG, QDdrugadministrationroute048drugindicationSCHIZOPHRENIAdrugstartdateformat102drugstartdate11/04/2013drugenddateformat102drugenddate16/05/2013actiondrug4

activesubstance

activesubstancenameFLUNITRAZEPAM

20)

drugcharacterization1medicinalproductCLOZARILdrugauthorizationnumb019758drugstructuredosagenumb125drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb12drugcumulativedosageunit003drugdosagetext125 MG, QDdrugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate21/01/2013drugenddateformat102drugenddate23/01/2013actiondrug2

activesubstance

activesubstancenameCLOZAPINE

openFDA Info on Medication

21)

drugcharacterization1medicinalproductCLOZARILdrugauthorizationnumb019758drugstructuredosagenumb250drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb12drugcumulativedosageunit003drugdosagetext250 MG, QDdrugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate01/03/2013drugenddateformat102drugenddate07/03/2013actiondrug2

activesubstance

activesubstancenameCLOZAPINE

openFDA Info on Medication

22)

drugcharacterization1medicinalproductCLOZARILdrugauthorizationnumb019758drugstructuredosagenumb275drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb12drugcumulativedosageunit003drugdosagetext275 MG, QDdrugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate08/03/2013drugenddateformat102drugenddate25/03/2013actiondrug2

activesubstance

activesubstancenameCLOZAPINE

openFDA Info on Medication

23)

activesubstance

activesubstancenameCLOZAPINE

openFDA Info on Medication

24)

drugcharacterization1medicinalproductLIMASdrugstructuredosagenumb600drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext600 MG, QDdrugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate12/07/2013actiondrug4

activesubstance

activesubstancenameLITHIUM CARBONATE

25)

drugcharacterization1medicinalproductCLARITINdrugstructuredosagenumb10drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext10 MG, QDdrugadministrationroute048drugindicationSEASONAL ALLERGYdrugstartdateformat102drugstartdate11/04/2013actiondrug4

activesubstance

activesubstancenameLORATADINE

openFDA Info on Medication

Application NumberNDA020704, NDA019658, ANDA075209, NDA021952, NDA021891, NDA021993Brand NameCLARITIN REDITABS, CLARITIN, CLARITIN LIQUI-GELSGeneric NameLORATADINEManufacturersBayer Healthcare LLC., Bayer HealthCare LLC., Bayer HealthCare LLCproduct_ndc 11523-4329, 11523-7157, 11523-0007, 11523-6655, 11523-0800, 11523-1527, 11523-72 ... Product TypeHUMAN OTC DRUGRouteORALActive IngredientsLORATADINERXCUI311373, 744830, 206805, 311372, 828269, 836338, 665078, 668469, 672558, 904026spl_id de083f49-281f-89b3-e053-2a95a90a6fcd, de08d044-d572-48cd-e053-2a95a90a619f, d443 ... spl_set_id b681ea25-d00b-4c8a-8054-cc6f983ce337, acf2d393-53d7-062f-e053-2995a90a0d60, ac32 ... Package NDC 11523-7157-2, 11523-7157-3, 11523-7157-4, 11523-7157-7, 11523-7157-8, 11523-7157 ... UNII7AJO3BO7QN

26)

drugcharacterization2medicinalproductQUETIAPINEdrugstructuredosagenumb700drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext700 MG, QDdrugadministrationroute048drugindicationSCHIZOPHRENIAdrugenddateformat102drugenddate07/02/2013actiondrug1

activesubstance

activesubstancenameQUETIAPINE

openFDA Info on Medication

Application Number ANDA207655, NDA022047, ANDA201109, ANDA077745, NDA020639, ANDA202152, ANDA211405 ... Brand Name QUETIAPINE FUMARATE, SEROQUEL XR, QUETIAPINE, SEROQUEL, QUETIAPINE EXTENDED RELE ... Generic NameQUETIAPINE, QUETIAPINE EXTENDED-RELEASEManufacturers Aurobindo Pharma Limited, AstraZeneca Pharmaceuticals LP, BluePoint Laboratories ... product_ndc 65862-873, 65862-874, 65862-875, 65862-876, 65862-877, 0310-0280, 0310-0282, 031 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsQUETIAPINE FUMARATERXCUI 721791, 721794, 721796, 853201, 895670, 721793, 721795, 721797, 853202, 895671, ... spl_id 9f1cee1e-be60-4cb5-b17d-0b5af10920f4, c3b26ed5-6f3a-4ca5-80a5-b98380040294, dd14 ... spl_set_id 6562eb60-0d70-4909-bd07-88d5c9241516, 473a3ac4-67f4-4782-baa9-7f9bdd8761f4, 874e ... Package NDC 65862-873-60, 65862-873-01, 65862-873-05, 65862-874-60, 65862-874-01, 65862-874- ... UNII2S3PL1B6UJ

27)

drugcharacterization2medicinalproductLITHIUM CARBONATE.drugstructuredosagenumb800drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext800 MG, QDdrugdosageformTABLETdrugadministrationroute048drugindicationSCHIZOPHRENIAdrugstartdateformat102drugstartdate28/12/2012actiondrug4

activesubstance

activesubstancenameLITHIUM CARBONATE

openFDA Info on Medication

Brand Name LITHIUM CARBONICUM, LITHIUM CARBONATE, LITHIUM CARBONATE ER, RHEUMATSM, LITHIUM ... Generic NameLITHIUM CARBONATE, LITHIUM CARBONATE EXTENDED-RELEASE TABLETManufacturers Boiron, Mylan Pharmaceuticals Inc., Heritage Pharmaceuticals Inc. d/b/a Avet Pha ... product_ndc 0220-3128, 0378-1300, 23155-763, 0054-2526, 0054-8528, 0054-4527, 0054-8526, 005 ... Product TypeHUMAN OTC DRUG, HUMAN PRESCRIPTION DRUGRouteORALActive IngredientsLITHIUM CARBONATEspl_id 861df6e6-46cc-632d-e053-2a91aa0ae9a3, 4dea5284-2539-43e3-8002-fed27008f189, 84eb ... spl_set_id 861df6e6-46cb-632d-e053-2a91aa0ae9a3, 785a0327-998b-4154-9461-b72cb78e2739, 074e ... Package NDC 0220-3128-41, 0378-1300-01, 0378-1300-05, 23155-763-05, 23155-763-01, 0054-8528- ... UNII2BMD2GNA4V, 5Z6E9K79YVApplication Number ANDA202288, ANDA205532, NDA017812, NDA018558, ANDA204445, ANDA090702, ANDA202219 ... RXCUI197891, 197889, 197890, 197893, 311355, 756059, 197892, 206786

28)

drugcharacterization2medicinalproductFLUNITRAZEPAMdrugstructuredosagenumb1drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext1 MG, QDdrugadministrationroute048drugstartdateformat102drugstartdate17/05/2013drugenddateformat102drugenddate06/06/2013actiondrug4

activesubstance

activesubstancenameFLUNITRAZEPAM

29)

drugcharacterization2medicinalproductSYOSEIRYUTOdrugstructuredosagenumb6drugstructuredosageunit002drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext6 G, QDdrugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate11/03/2014drugenddateformat102drugenddate20/03/2014actiondrug3

activesubstance

activesubstancenameHERBALS

30)

activesubstance

activesubstancenameCLOZAPINE

openFDA Info on Medication

31)

drugcharacterization1medicinalproductLEUCON /00300201/drugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext20 MG, QDdrugadministrationroute048drugindicationNEUTROPHIL COUNT DECREASEDdrugstartdateformat102drugstartdate02/08/2013actiondrug4

activesubstance

activesubstancenameADENINE

32)

drugcharacterization1medicinalproductQUAZEPAM.drugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb330drugcumulativedosageunit003drugdosagetext20 MG, QDdrugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate21/11/2013drugenddateformat102drugenddate14/07/2014actiondrug1

activesubstance

activesubstancenameQUAZEPAM

openFDA Info on Medication

33)

drugcharacterization1medicinalproductLANDSENdrugstructuredosagenumb2drugstructuredosageunit003drugdosagetext2 MGdrugadministrationroute048drugindicationSCHIZOPHRENIAdrugstartdateformat102drugstartdate11/04/2013drugenddateformat102drugenddate20/03/2014actiondrug1

activesubstance

activesubstancenameCLONAZEPAM

34)

drugcharacterization2medicinalproductOLANZAPINE.drugstructuredosagenumb20drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext20 MG, QDdrugadministrationroute048drugindicationSCHIZOPHRENIAdrugenddateformat102drugenddate07/02/2013actiondrug1

activesubstance

activesubstancenameOLANZAPINE

openFDA Info on Medication

Application Number ANDA204319, ANDA201588, ANDA202050, ANDA076255, NDA020592, NDA021086, NDA021253, ... Brand NameOLANZAPINE, ZYPREXA, ZYPREXA ZYDIS, ZYPREXA INTRAMUSCULARGeneric NameOLANZAPINEManufacturers Virtus Pharmaceuticals, LLC, Sandoz Inc, Burel Pharmaceuticals, LLC, Dr. Reddy's ... product_ndc 69543-380, 69543-381, 69543-382, 69543-383, 69543-384, 69543-385, 0781-9105, 355 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, INTRAMUSCULARActive IngredientsOLANZAPINERXCUI 200034, 283639, 312077, 312078, 312079, 314154, 485968, 153046, 153047, 153048, ... spl_id e78e66e4-82ab-47a9-8633-d304cb6bac1e, a0f9cb84-1dee-4dc5-96b7-ce259903b940, eda6 ... spl_set_id 6a5db723-0f21-417e-a95c-cf0c438e8b44, c44a96cc-817d-4eb5-a13a-00977f76e666, 1ae6 ... Package NDC 69543-380-30, 69543-380-90, 69543-381-30, 69543-381-90, 69543-382-30, 69543-382- ... NUIN0000175430Established Pharmacologic ClassAtypical Antipsychotic [EPC]UNIIN7U69T4SZR

35)

drugcharacterization2medicinalproductESZOPICLONE.drugstructuredosagenumb2drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext2 MG, QDdrugdosageformTABLETdrugadministrationroute048drugindicationSCHIZOPHRENIAdrugenddateformat102drugenddate30/01/2013actiondrug1

activesubstance

activesubstancenameESZOPICLONE

openFDA Info on Medication

Application Number ANDA091124, ANDA091166, ANDA091103, ANDA091113, ANDA091024, ANDA208451, ANDA2029 ... Brand NameESZOPICLONE, LUNESTAGeneric NameESZOPICLONEManufacturers Lupin Pharmaceuticals, Inc., Glenmark Pharmaceuticals Inc. USA, Sun Pharmaceutic ... product_ndc 68180-322, 68180-323, 68180-324, 68462-382, 68462-383, 68462-384, 47335-586, 473 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORAL, OROPHARYNGEALActive IngredientsESZOPICLONERXCUI485440, 485442, 485465, 540407, 540409, 540411spl_id c15b2322-c078-46c1-8959-9288faaab19e, 8d6002b1-95d9-445c-8ace-e6dccea36852, 95e9 ... spl_set_id 7068c455-691e-4c56-9857-b7b4e13f4784, 584dc66c-063a-4552-a056-74b811e2bc80, 8bb1 ... Package NDC 68180-322-01, 68180-322-11, 68180-322-13, 68180-323-01, 68180-323-02, 68180-323- ... UNIIUZX80K71OE

36)

drugcharacterization2medicinalproductTRIHEXYPHENIDYL HYDROCHLORIDE.drugstructuredosagenumb4drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext4 MG, QDdrugadministrationroute048drugindicationPARKINSON^S DISEASEdrugenddateformat102drugenddate23/01/2013actiondrug1

activesubstance

activesubstancenameTRIHEXYPHENIDYL HYDROCHLORIDE

openFDA Info on Medication

Application NumberANDA040251, ANDA091630, ANDA040254, ANDA040177, ANDA084363, ANDA084364Brand NameTRIHEXYPHENIDYL HYDROCHLORIDEGeneric NameTRIHEXYPHENIDYL HYDROCHLORIDEManufacturers Akorn, Bionpharma Inc., Novitium Pharma LLC, Pharmaceutical Associates, Inc., Ri ... product_ndc 61748-054, 69452-241, 69452-242, 70954-211, 70954-212, 0121-0658, 16571-160, 165 ... Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsTRIHEXYPHENIDYL HYDROCHLORIDEspl_id 3a17b358-46b6-4e74-9788-ccb8acf9ca8f, 4d4d473e-4f84-43e7-bb17-49e8dc1e97fd, 8360 ... spl_set_id 294cd88d-d9e8-4938-b4be-c3adc4a35de0, 4d4d473e-4f84-43e7-bb17-49e8dc1e97fd, 8360 ... Package NDC 61748-054-16, 69452-241-20, 69452-241-32, 69452-242-20, 69452-242-32, 70954-211- ... UNIIAO61G82577RXCUI905269, 905283

37)

drugcharacterization2medicinalproductDEPASdrugstructuredosagenumb3drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext3 MG, QDdrugadministrationroute048drugindicationSCHIZOPHRENIAdrugstartdateformat102drugstartdate21/03/2014drugenddateformat102drugenddate03/04/2014actiondrug1

activesubstance

activesubstancenameETIZOLAM

38)

drugcharacterization1medicinalproductCLOZARILdrugauthorizationnumb019758drugstructuredosagenumb150drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb12drugcumulativedosageunit003drugdosagetext150 MG, QDdrugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate24/01/2013drugenddateformat102drugenddate26/01/2013actiondrug2

activesubstance

activesubstancenameCLOZAPINE

openFDA Info on Medication

39)

drugcharacterization1medicinalproductCLOZARILdrugauthorizationnumb019758drugstructuredosagenumb175drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb12drugcumulativedosageunit003drugdosagetext175 MG, QDdrugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate27/01/2013drugenddateformat102drugenddate29/01/2013actiondrug2

activesubstance

activesubstancenameCLOZAPINE

openFDA Info on Medication

40)

drugcharacterization1medicinalproductCLOZARILdrugauthorizationnumb019758drugstructuredosagenumb275drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb12drugcumulativedosageunit003drugdosagetext275 MG, QDdrugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate17/12/2014drugenddateformat102drugenddate24/12/2014actiondrug2

activesubstance

activesubstancenameCLOZAPINE

openFDA Info on Medication

41)

drugcharacterization1medicinalproductLIMASdrugstructuredosagenumb700drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext700 MG, QDdrugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate05/07/2013drugenddateformat102drugenddate11/07/2013actiondrug4

activesubstance

activesubstancenameLITHIUM CARBONATE

42)

drugcharacterization1medicinalproductLANDSENdrugstructuredosagenumb2drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext2 MG, QDdrugadministrationroute048drugstartdateformat102drugstartdate27/03/2014actiondrug1

activesubstance

activesubstancenameCLONAZEPAM

43)

drugcharacterization2medicinalproductSYOSEIRYUTOdrugstructuredosagenumb9drugstructuredosageunit002drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext9 G, QDdrugadministrationroute048drugstartdateformat102drugstartdate21/03/2014actiondrug3

activesubstance

activesubstancenameHERBALS

44)

drugcharacterization1medicinalproductCLOZARILdrugauthorizationnumb019758drugstructuredosagenumb25drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb12drugcumulativedosageunit003drugdosagetext25 MG, QDdrugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate11/01/2013drugenddateformat102drugenddate13/01/2013actiondrug2

activesubstance

activesubstancenameCLOZAPINE

openFDA Info on Medication

45)

drugcharacterization1medicinalproductCLOZARILdrugauthorizationnumb019758drugstructuredosagenumb50drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb12drugcumulativedosageunit003drugdosagetext50 MG, QDdrugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate14/01/2013drugenddateformat102drugenddate16/01/2013actiondrug2

activesubstance

activesubstancenameCLOZAPINE

openFDA Info on Medication

46)

drugcharacterization1medicinalproductCLOZARILdrugauthorizationnumb019758drugstructuredosagenumb100drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb12drugcumulativedosageunit003drugdosagetext100 MG, QDdrugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate19/01/2013drugenddateformat102drugenddate20/01/2013actiondrug2

activesubstance

activesubstancenameCLOZAPINE

openFDA Info on Medication

47)

activesubstance

activesubstancenameCLOZAPINE

openFDA Info on Medication

48)

drugcharacterization2medicinalproductFLUNITRAZEPAMdrugstructuredosagenumb2drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext2 MG, QDdrugadministrationroute048drugstartdateformat102drugstartdate15/07/2014actiondrug4

activesubstance

activesubstancenameFLUNITRAZEPAM

49)

drugcharacterization1medicinalproductCLOZARILdrugauthorizationnumb019758drugstructuredosagenumb12.5drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb12drugcumulativedosageunit003drugdosagetext12.5 MG, QDdrugdosageformTABLETdrugadministrationroute048drugindicationSCHIZOPHRENIAdrugstartdateformat102drugstartdate10/01/2013drugenddateformat102drugenddate10/01/2013actiondrug2

activesubstance

activesubstancenameCLOZAPINE

openFDA Info on Medication

50)

activesubstance

activesubstancenameCLOZAPINE

openFDA Info on Medication

51)

drugcharacterization1medicinalproductCLOZARILdrugauthorizationnumb019758drugstructuredosagenumb325drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb12drugcumulativedosageunit003drugdosagetext325 MG, QDdrugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate19/04/2013drugenddateformat102drugenddate02/05/2013actiondrug2

activesubstance

activesubstancenameCLOZAPINE

openFDA Info on Medication

52)

drugcharacterization1medicinalproductCLOZARILdrugauthorizationnumb019758drugstructuredosagenumb375drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb12drugcumulativedosageunit003drugdosagetext375 MG, QDdrugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate08/08/2014drugenddateformat102drugenddate21/10/2014actiondrug2

activesubstance

activesubstancenameCLOZAPINE

openFDA Info on Medication

53)

drugcharacterization1medicinalproductCLOZARILdrugauthorizationnumb019758drugstructuredosagenumb300drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugcumulativedosagenumb12drugcumulativedosageunit003drugdosagetext300 MG, QDdrugdosageformTABLETdrugadministrationroute048drugstartdateformat102drugstartdate19/11/2014drugenddateformat102drugenddate16/12/2014actiondrug2

activesubstance

activesubstancenameCLOZAPINE

openFDA Info on Medication

54)

drugcharacterization2medicinalproductHORIZONdrugstructuredosagenumb5drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugdosagetext5 MG, QDdrugadministrationroute048drugindicationSCHIZOPHRENIAdrugstartdateformat102drugstartdate30/05/2013drugenddateformat102drugenddate30/05/2013actiondrug1

activesubstance

activesubstancenameDIAZEPAM

summary

narrativeincludeclinicalCASE EVENT DATE: 20130131

Adverse Event Report

Report

Report Duplicate

Primary Source

Sender

Receiver

Patient

Reaction

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Drug

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activesubstance

openFDA Info on Medication

2)

activesubstance

openFDA Info on Medication

3)

activesubstance

openFDA Info on Medication

4)

activesubstance

openFDA Info on Medication

5)

activesubstance

openFDA Info on Medication

6)

activesubstance

7)

activesubstance

openFDA Info on Medication

8)

activesubstance

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activesubstance

10)

activesubstance

openFDA Info on Medication

11)

activesubstance

12)

activesubstance

13)

activesubstance

openFDA Info on Medication

14)

activesubstance

openFDA Info on Medication

15)

activesubstance

openFDA Info on Medication

16)

activesubstance

openFDA Info on Medication

17)

activesubstance

18)

activesubstance

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activesubstance

20)

activesubstance

openFDA Info on Medication

21)

activesubstance

openFDA Info on Medication

22)