{ "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": "2026-05-19", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "submissions": [ { "submission_type": "SUPPL", "submission_number": "15", "submission_status": "AP", "submission_status_date": "19861014", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "13", "submission_status": "AP", "submission_status_date": "19840723", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "11", "submission_status": "AP", "submission_status_date": "19830810", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "8", "submission_status": "AP", "submission_status_date": "19830414", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "28", "submission_status": "AP", "submission_status_date": "20001011", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "42", "submission_status": "AP", "submission_status_date": "20140910", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "34", "submission_status": "AP", "submission_status_date": "20070727", "review_priority": "N/A", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)", "application_docs": [ { "id": "14958", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018248s034_ltr.pdf", "date": "20070730", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "26", "submission_status": "AP", "submission_status_date": "19990222", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "20118", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/018248_S026_OXYTOCIN_AP.pdf", "date": "20070709", "type": "Review" } ] }, { "submission_type": "SUPPL", "submission_number": "18", "submission_status": "AP", "submission_status_date": "19880216", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "24", "submission_status": "AP", "submission_status_date": "19971017", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "16", "submission_status": "AP", "submission_status_date": "19860919", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "22", "submission_status": "AP", "submission_status_date": "19950113", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "14", "submission_status": "AP", "submission_status_date": "19850314", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "20", "submission_status": "AP", "submission_status_date": "19941216", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "12", "submission_status": "AP", "submission_status_date": "19831108", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "49", "submission_status": "AP", "submission_status_date": "20220920", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "72123", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/018248Orig1s049ltr.pdf", "date": "20220921", "type": "Letter" }, { "id": "72125", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018248s049lbl.pdf", "date": "20220921", "type": "Label" } ] }, { "submission_type": "ORIG", "submission_number": "1", "submission_status": "AP", "submission_status_date": "19800709", "review_priority": "STANDARD", "submission_class_code": "TYPE 5", "submission_class_code_description": "Type 5 - New Formulation or New Manufacturer" }, { "submission_type": "SUPPL", "submission_number": "9", "submission_status": "AP", "submission_status_date": "19821112", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "7", "submission_status": "AP", "submission_status_date": "19820310", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "27", "submission_status": "AP", "submission_status_date": "20000531", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "20119", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/018248_S027_OXYTOCIN_AP.pdf", "date": "20070709", "type": "Review" } ] }, { "submission_type": "SUPPL", "submission_number": "19", "submission_status": "AP", "submission_status_date": "19990120", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "25", "submission_status": "AP", "submission_status_date": "19990702", "review_priority": "STANDARD", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "17", "submission_status": "AP", "submission_status_date": "19870224", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "23", "submission_status": "AP", "submission_status_date": "19941123", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" } ], "application_number": "NDA018248", "sponsor_name": "FRESENIUS KABI USA", "openfda": { "application_number": [ "NDA018248" ], "brand_name": [ "OXYTOCIN" ], "generic_name": [ "OXYTOCIN" ], "manufacturer_name": [ "Fresenius Kabi USA, LLC" ], "product_ndc": [ "63323-012", "65219-021" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAMUSCULAR", "INTRAVENOUS" ], "substance_name": [ "OXYTOCIN" ], "rxcui": [ "238013", "1791721" ], "spl_id": [ "143745a3-4e90-49fc-9014-812276fe329f", "9ac3d1b0-5944-4a20-87b1-423a712f429a", "3649e8ed-929c-4600-9d63-3d77fbe3a0f5" ], "spl_set_id": [ "6d7d1280-f286-4f39-89f3-2b96571810e6", "4c4c4b69-8bf7-472c-aafe-29805ba5c965", "c7fd585a-99b7-4309-b003-a6cbef05372c" ], "package_ndc": [ "63323-012-17", "63323-012-07", "65219-021-00", "65219-021-01", "63323-012-06", "63323-012-10", "63323-012-02", "63323-012-30", "63323-012-03", "63323-012-11" ], "nui": [ "N0000009705", "N0000175828", "M0015703" ], "pharm_class_pe": [ "Increased Uterine Smooth Muscle Contraction or Tone [PE]" ], "pharm_class_epc": [ "Oxytocic [EPC]" ], "pharm_class_cs": [ "Oxytocin [CS]" ], "unii": [ "1JQS135EYN" ] }, "products": [ { "product_number": "002", "reference_drug": "Yes", "brand_name": "OXYTOCIN", "active_ingredients": [ { "name": "OXYTOCIN", "strength": "100USP UNITS/10ML (10USP UNITS/ML)" } ], "reference_standard": "Yes", "dosage_form": "INJECTABLE", "route": "INJECTION", "marketing_status": "Prescription", "te_code": "AP" }, { "product_number": "003", "reference_drug": "Yes", "brand_name": "OXYTOCIN", "active_ingredients": [ { "name": "OXYTOCIN", "strength": "300USP UNITS/30ML (10USP UNITS/ML)" } ], "reference_standard": "Yes", "dosage_form": "INJECTABLE", "route": "INJECTION", "marketing_status": "Prescription" }, { "product_number": "001", "reference_drug": "Yes", "brand_name": "OXYTOCIN", "active_ingredients": [ { "name": "OXYTOCIN", "strength": "10USP UNITS/ML (10USP UNITS/ML)" } ], "reference_standard": "Yes", "dosage_form": "INJECTABLE", "route": "INJECTION", "marketing_status": "Prescription", "te_code": "AP" } ] } ] }