{ "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": "2026-08-28", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "submissions": [ { "submission_type": "SUPPL", "submission_number": "1", "submission_status": "AP", "submission_status_date": "20160802", "review_priority": "UNKNOWN", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "4", "submission_status": "AP", "submission_status_date": "20191127", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "2", "submission_status": "AP", "submission_status_date": "20161229", "review_priority": "UNKNOWN", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "ORIG", "submission_number": "1", "submission_status": "AP", "submission_status_date": "20160526", "review_priority": "STANDARD", "submission_class_code": "UNKNOWN" } ], "application_number": "ANDA207957", "sponsor_name": "HIKMA", "openfda": { "application_number": [ "ANDA207957" ], "brand_name": [ "WELBY FLUTICASONE", "CHILDRENS ALLERGY RELIEF", "ALLERGY RELIEF", "DG HEALTH CHILDRENS ALLERGY RELIEF NASAL", "TOPCARE ALLERGY RELIEF NASAL", "EQUATE ALLERGY RELIEF", "TOPCARE CHILDRENS ALLERGY RELIEF NASAL 24 HOUR", "CHILDRENS ALLERGY", "NASOPRO 24", "ALLERGY RELIEF NASAL", "EQUALINE FLUTICASONE PROPIONATE", "CHILDRENS NASOPRO", "ALLERGY NASAL", "CAREONE CHILDRENS ALLERGY RELIEF", "KIRKLAND SIGNATURE ALLER FLO", "LEADER FLUTICASONE PROPIONATE", "RUGBY FLUTICASONE PROPIONATE NASAL", "CAREONE ALLERGY RELIEF", "FOSTER AND THRIVE ALLERGY RELIEF", "GOOD SENSE 24 HOUR ALLERGY NASAL", "DG HEALTH ALLERGY RELIEF NASAL", "BASIC CARE ALLERGY RELIEF NASAL", "FLUTICASONE PROPIONATE NASAL", "EXCHANGE SELECT ALLERGY RELIEF", "UP AND UP ALLERGY RELIEF NASAL", "BASIC CARE CHILDRENS ALLERGY RELIEF NASAL", "24 HOUR ALLERGY NASAL", "EQUATE CHILDRENS ALLERGY RELIEF", "GOOD NEIGHBOR PHARMACY FLUTICASONE PROPIONATE", "TOPCARE FLUTICASONE PROPIONATE NASAL" ], "generic_name": [ "FLUTICASONE PROPIONATE" ], "manufacturer_name": [ "Aldi Inc", "CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED", "Meijer Distribution Inc", "Dolgencorp Inc", "Topco Associates LLC", "WALMART INC.", "H E B", "Publix Super Markets Inc", "United Natural Foods, Inc. dba UNFI", "American Sales Company", "Costco Wholesale Company", "Cardinal Health 110, LLC. dba Leader", "Rugby Laboratories", "Strategic Sourcing Services LLC", "L. 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