Report

reporttype1receiptdateformat102companynumbUS-DRREDDYS-USA/USA/14/0037663occurcountryUSVersion of Safety Report ID2receivedateformat102duplicate1transmissiondateformat102fulfillexpeditecriteria2Safety Report ID10089224Date Received21/04/2014transmissiondate12/12/2014serious2Date Last Updated21/04/2014primarysourcecountryUS

Receiver

receivertype6receiverorganizationFDA

Primary Source

reportercountryUSqualification5

Sender

sendertype2senderorganizationFDA-Public Use

Patient

Onset Age15Unit of Onset AgeyearsSexMale

Contents

Reaction
- 1)
- 2)
- 3)
- 4)
Drug

Reaction

1)

reactionmeddraversionpt17.0ReactionLip dryOutcomeUnknown

2)

reactionmeddraversionpt17.0ReactionOral mucosal exfoliationOutcomeUnknown

3)

reactionmeddraversionpt17.0ReactionDrug ineffectiveOutcomeUnknown

4)

reactionmeddraversionpt17.0ReactionProduct quality issueOutcomeUnknown

Drug

1)

drugcharacterization1medicinalproductZENATANEdrugbatchnumbAYW223,AYW223drugauthorizationnumb202099drugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb1drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugindicationACNEdrugstartdateformat102drugstartdate14/12/2013actiondrug4drugrecurreadministration3

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)

drugcharacterization1medicinalproductZENATANEdrugbatchnumbAYW223,AYW223drugauthorizationnumb202099drugstructuredosagenumb40drugstructuredosageunit003drugseparatedosagenumb2drugintervaldosageunitnumb1drugintervaldosagedefinition804drugadministrationroute048drugstartdateformat102drugstartdate11/01/2014actiondrug4drugrecurreadministration3

openFDA Info on Medication

Report Duplicate

duplicatesourceDR REDDYSduplicatenumbUS-DRREDDYS-USA/USA/14/0037663

Adverse Event Report

Report

Receiver

Primary Source

Sender

Patient

Reaction

1)

2)

3)

4)

Drug

1)

openFDA Info on Medication

2)

openFDA Info on Medication

Report Duplicate

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