Adverse Event Report

Report

reporttype1receiptdateformat102companynumbUS-DRREDDYS-USA/USA/14/0045132occurcountryUSVersion of Safety Report ID2receivedateformat102duplicate1transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10718506Date Received19/01/2015transmissiondate21/08/2015serious2Date Last Updated16/04/2015primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification3

Sender

sendertype2senderorganizationFDA-Public Use

Patient

SexMale

Reaction

1)

reactionmeddraversionpt18.0ReactionAldolase increasedOutcomeUnknown

2)

reactionmeddraversionpt18.0ReactionBlood creatine phosphokinase increasedOutcomeUnknown

3)

reactionmeddraversionpt18.0ReactionAspartate aminotransferase increasedOutcomeUnknown

4)

reactionmeddraversionpt18.0ReactionAlanine aminotransferase increasedOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductZENATANEdrugbatchnumbUNKNOWNdrugauthorizationnumb202099drugadministrationroute048drugstartdateformat102drugstartdate11/11/2014actiondrug1drugrecurreadministration3

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)

drugcharacterization1medicinalproductZENATANEdrugbatchnumbUNKNOWNdrugauthorizationnumb202099drugadministrationroute048drugindicationPRODUCT USED FOR UNKNOWN INDICATIONdrugstartdateformat102drugstartdate05/09/2014drugenddateformat102drugenddate19/12/2014actiondrug1drugrecurreadministration3

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

Report Duplicate

duplicatesourceDR REDDYSduplicatenumbUS-DRREDDYS-USA/USA/14/0045132