Report

reporttype1receiptdateformat102companynumbUS-TEVA-479093USAoccurcountryUSVersion of Safety Report ID1receivedateformat102duplicate1transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10149263Date Received02/05/2014transmissiondate12/12/2014serious2Date Last Updated02/05/2014primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Patient

SexMale

Contents

Reaction
- 1)
- 2)
- 3)
Drug

Reaction

1)

reactionmeddraversionpt17.0ReactionDrug ineffectiveOutcomeUnknown

2)

reactionmeddraversionpt17.0ReactionAcneOutcomeUnknown

3)

reactionmeddraversionpt17.0ReactionContusionOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductCLARAVISdrugauthorizationnumb076135drugstructuredosagenumb40drugstructuredosageunit003drugdosageformCAPSULEdrugadministrationroute048drugindicationACNEactiondrug5

openFDA Info on Medication

Application NumberANDA076356, ANDA076135Brand NameCLARAVISGeneric NameISOTRETINOINManufacturersTeva Pharmaceuticals USA, Inc.product_ndc0555-1054, 0555-1055, 0555-1056, 0555-1057Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsISOTRETINOINRXCUI197843, 197844, 197845, 403930, 404059, 404062, 404065, 643488spl_ide462821c-84c4-4009-a26e-da92790126bfspl_set_ida31fd109-d0fd-4ab9-ba98-a3d64333c18dPackage NDC 0555-1054-60, 0555-1054-86, 0555-1054-56, 0555-1055-60, 0555-1055-86, 0555-1055- ... NUIN0000175607, M0018962Established Pharmacologic ClassRetinoid [EPC]Chemical StructureRetinoids [CS]UNIIEH28UP18IF

2)

drugcharacterization1medicinalproductAMNESTEEMdrugdosageformCAPSULE

openFDA Info on Medication

Application NumberANDA075945Brand NameAMNESTEEMGeneric NameISOTRETINOINManufacturersMylan Pharmaceuticals Inc.product_ndc0378-6611, 0378-6612, 0378-6614Product TypeHUMAN PRESCRIPTION DRUGRouteORALActive IngredientsISOTRETINOINRXCUI197843, 197844, 197845, 404058, 404061, 404064spl_id47bb51b9-0613-4708-905f-e950dbfa5127spl_set_idb2cb63c9-f825-4991-9a2c-6260f1bbcc2cPackage NDC 0378-6611-85, 0378-6611-93, 0378-6612-85, 0378-6612-93, 0378-6614-85, 0378-6614- ... NUIN0000175607, M0018962Established Pharmacologic ClassRetinoid [EPC]Chemical StructureRetinoids [CS]UNIIEH28UP18IF

Report Duplicate

duplicatesourceTEVAduplicatenumbUS-TEVA-479093USA

Adverse Event Report

Report

Receiver

Primary Source

Sender

Patient

Reaction

1)

2)

3)

Drug

1)

openFDA Info on Medication

2)

openFDA Info on Medication

Report Duplicate

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