{ "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": "28", "submission_status": "AP", "submission_status_date": "20210818", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "18", "submission_status": "AP", "submission_status_date": "20160426", "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": "20060925", "application_docs": [ { "id": "31226", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077351s000LTR.pdf", "date": "20060927", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "23", "submission_status": "AP", "submission_status_date": "20210218", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" } ], "application_number": "ANDA077351", "sponsor_name": "PERRIGO R AND D", "openfda": { "application_number": [ "ANDA077351" ], "brand_name": [ "ACID RELIEF", "ACID REDUCER", "HEARTBURN PREVENTION", "ACID CONTROLLER", "RUGBY FAMOTIDINE", "FOSTER AND THRIVE ACID REDUCER", "MEMBERS MARK ACID PEP", "BASIC CARE ACID REDUCER", "CAREONE ACID RELIEF", "TOPCARE ACID REDUCER", "DG HEALTH ACID REDUCER", "EQUALINE HEARTBURN PREVENTION", "EQUATE FAMOTIDINE", "GOOD SENSE ACID REDUCER", "BERKLEY AND JENSEN FAMOTIDINE", "ROLAIDS ACID DEFENSE", "HEARTBURN RELIEF", "DG HEALTH HEARTBURN PREVENTION", "SIGNATURE CARE ACID CONTROLLER MAXIMUM STRENGTH", "KIRKLAND SIGNATURE ACID CONTROLLER", "LEADER ACID REDUCER", "BASIC CARE HEARTBURN PREVENTION", "MAXIMUM STRENGTH", "MAJOR HEARTBURN RELIEF MAXIMUM STRENGTH" ], "generic_name": [ "FAMOTIDINE", "FAMOTITINE" ], "manufacturer_name": [ "Rite Aid Corporation", "Publix Super Markets Inc", "Kroger Company", "H E B", "Rugby Laboratories", "Safeway", "CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED", "Walgreen Company", "Strategic Sourcing Services LLC", "Sam's West Inc", "Amazon.com Services LLC", "Retail Business Services, LLC", "Topco Associates LLC", "Dolgencorp Inc", "United Natural Foods, Inc. dba UNFI", "Wal-Mart Stores Inc", "American Sales Company", "L. 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