{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-04-28", "results": { "skip": 0, "limit": 1, "total": 4720 } }, "results": [ { "safetyreportversion": "1", "safetyreportid": "10006638", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20141002", "reporttype": "1", "serious": "2", "receivedateformat": "102", "receivedate": "20140313", "receiptdateformat": "102", "receiptdate": "20140313", "fulfillexpeditecriteria": "2", "companynumb": "US-PFIZER INC-2014068410", "duplicate": "1", "reportduplicate": { "duplicatesource": "PFIZER", "duplicatenumb": "US-PFIZER INC-2014068410" }, "primarysource": { "reportercountry": "US", "qualification": "5" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Skin disorder", "reactionoutcome": "1" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "CLINDAMYCIN PHOSPHATE", "drugauthorizationnumb": "050537", "drugdosagetext": "UNK", "drugdosageform": "CUTANEOUS SOLUTION", "drugadministrationroute": "061", "actiondrug": "5", "openfda": { "application_number": [ "ANDA090108", "NDA050782", "NDA215650", "ANDA208084", "ANDA214604", "ANDA064050", "ANDA209846", "ANDA212842", "ANDA216587", "ANDA212466", "ANDA208767", "ANDA210004", "ANDA214668", "NDA050615", "NDA050600", "ANDA090785", "NDA208083", "ANDA215607", "ANDA210778", "ANDA065049", "ANDA214251", "ANDA212104", "ANDA212438", "NDA050680", "ANDA064159", "ANDA064160", "ANDA065067", "ANDA218942", "ANDA214526", "ANDA211872", "ANDA065513", "ANDA065139", "NDA050441", "ANDA218300", "ANDA214052", "NDA050767", "ANDA065184", "ANDA219612", "NDA050793" ], "brand_name": [ "CLINDAMYCIN", "CLINDAMYCIN PHOSPHATE", "XACIATO", "CLINDACIN ETZ", "CLINDACIN P", "CLEOCIN PHOSPHATE", "CLEOCIN", "CLEOCIN T", "CLINDESSE", "CLINDACIN" ], "generic_name": [ "CLINDAMYCIN PHOSPHATE", "CLINDAMYCIN PHOSPHATE GEL USP, 1%", "CLINDAMYCIN PHOSPHATE TOPICAL" ], "manufacturer_name": [ "Sagent Pharmaceuticals", "Oceanside Pharmaceuticals", "Organon LLC", "Baxter Healthcare Corporation", "Padagis Israel Pharmaceuticals Ltd", "Chartwell RX, LLC", "Solaris Pharma Corporation", "Zydus Lifesciences Limited", "Alembic Pharmaceuticals Limited", "Viona Pharmaceuticals Inc", "Taro Pharmaceuticals U.S.A., Inc.", "Amneal Pharmaceuticals NY LLC", "Mylan Pharmaceuticals Inc.", "Baxter Healthcare Company", "Encube Ethicals, Inc.", "GLENMARK PHARMACEUTICALS INC., USA", "Eurofarma, Inc.", "NORTHSTAR RX LLC", "E. 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