Report reporttype 1 receiptdateformat 102 companynumb FR-RANBAXY-2015R1-92984 occurcountry FR Version of Safety Report ID 2 receivedateformat 102 duplicate 1 transmissiondateformat 102 fulfillexpeditecriteria 1 Safety Report ID 10801668 Date Received 17/02/2015 transmissiondate 13/01/2021 serious 2 Date Last Updated 26/10/2020 primarysourcecountry FR Receiver receivertype 6 receiverorganization FDA Primary Source reportercountry FR qualification 3 literaturereference
DUCROUX E, OCAMPO MA, KANITAKIS J, MORELON E, JULLIEN D, FAURE M, ET AL. HIDRADE ...
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Sender sendertype 2 senderorganization FDA-Public Use Patient Onset Age 23 Unit of Onset Age years Sex Male Reaction 1) reactionmeddraversionpt 23.1 Reaction Condition aggravated Outcome Recovered/resolved Drug 1) drugcharacterization 1 medicinalproduct ISOTRETINOIN. drugauthorizationnumb 76041 drugstructuredosagenumb 20 drugstructuredosageunit 003 drugdosagetext 20 MG, DAILY drugadministrationroute 065 drugindication ACNE drugstartdateformat 610 drugstartdate /04/2010 actiondrug 5 drugadditional 3 activesubstance activesubstancename ISOTRETINOIN openFDA Info on Medication Application Number
NDA211913, NDA021951, ANDA202099, ANDA076356, ANDA076135, ANDA075945, ANDA076485 ...
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Brand Name
ABSORICA LD, ABSORICA, ZENATANE, ACCUTANE, CLARAVIS, ISOTRETINOIN, AMNESTEEM, MY ...
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Generic Name ISOTRETINOIN Manufacturers
Sun Pharmaceutical Industries, Inc., Dr. Reddy's Laboratories Limited, JG Pharma ...
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product_ndc
10631-002, 10631-115, 10631-116, 10631-117, 10631-118, 10631-133, 10631-134, 106 ...
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Product Type HUMAN PRESCRIPTION DRUG Route ORAL Active Ingredients ISOTRETINOIN RXCUI
197843, 197844, 197845, 403930, 1299203, 1300006, 1300014, 1300016, 1547561, 154 ...
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spl_id
a8d4793a-5043-40e1-b623-35812733499f, 1f5178c1-0f6f-824d-d0ee-1b973377ccc6, a599 ...
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spl_set_id
3ef0cff8-19c1-4441-b780-fca6c7ee1615, 27b3cf26-f22e-5b70-1c24-009933b7c6ee, a41c ...
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Package NDC
10631-115-69, 10631-115-31, 10631-116-69, 10631-116-31, 10631-117-69, 10631-117- ...
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NUI N0000175607, M0018962 Established Pharmacologic Class Retinoid [EPC] Chemical Structure Retinoids [CS] UNII EH28UP18IF Report Duplicate duplicatesource RANBAXY duplicatenumb FR-RANBAXY-2015R1-92984
