Adverse Event Report

Report

Version of Safety Report ID1Safety Report ID10760372primarysourcecountryUSoccurcountryUStransmissiondateformat102transmissiondate21/07/2015reporttype1serious1seriousnesshospitalization1receivedateformat102Date Received04/02/2015receiptdateformat102Date Last Updated04/02/2015fulfillexpeditecriteria2companynumbUS-DRREDDYS-USA/USA/14/0044309duplicate1

Report Duplicate

duplicatesourceDR REDDYSduplicatenumbUS-DRREDDYS-USA/USA/14/0044309

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Receiver

receivertype6receiverorganizationFDA

Patient

Onset Age55Unit of Onset AgeyearsSexMale

Reaction

1)

reactionmeddraversionpt18.0ReactionParaesthesiaOutcomeRecovered/resolved

Drug

1)

drugcharacterization1medicinalproductESZOPICLONE.drugbatchnumbUNKNOWNdrugauthorizationnumb091024drugdosageformTABLETdrugadministrationroute065drugindicationINSOMNIAdrugstartdateformat610drugstartdate/09/2014drugenddateformat102drugenddate06/11/2014actiondrug1drugrecurreadministration3

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

summary

narrativeincludeclinicalCASE EVENT DATE: 20141107