{ "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": "27", "submission_status": "AP", "submission_status_date": "19750221", "review_priority": "PRIORITY", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "41", "submission_status": "AP", "submission_status_date": "19810818", "review_priority": "PRIORITY", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "33", "submission_status": "AP", "submission_status_date": "19780503", "review_priority": "PRIORITY", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "31", "submission_status": "AP", "submission_status_date": "19770705", "review_priority": "PRIORITY", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "66", "submission_status": "AP", "submission_status_date": "20130222", "review_priority": "PRIORITY", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)", "application_docs": [ { "id": "10884", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/016320s066lbl.pdf", "date": "20130226", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "58", "submission_status": "AP", "submission_status_date": "20030206", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "438", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/16320slr057,058ltr.pdf", "date": "20030206", "type": "Letter" }, { "id": "33160", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/16320slr057_Myambutol_lbl.pdf", "date": "20030206", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "56", "submission_status": "AP", "submission_status_date": "20011010", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "33159", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/16320s56lbl.pdf", "date": "20030610", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "54", "submission_status": "AP", "submission_status_date": "19980508", "review_priority": "PRIORITY", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "46", "submission_status": "AP", "submission_status_date": "19870625", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "60", "submission_status": "AP", "submission_status_date": "20040324", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "12986", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/16320slr060ltr.pdf", "date": "20040328", "type": "Letter" }, { "id": "33161", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/16320slr060_myambutol_lbl.pdf", "date": "20040405", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "38", "submission_status": "AP", "submission_status_date": "19790403", "review_priority": "PRIORITY", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "52", "submission_status": "AP", "submission_status_date": "19871102", "review_priority": "PRIORITY", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "44", "submission_status": "AP", "submission_status_date": "19820224", "review_priority": "PRIORITY", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "36", "submission_status": "AP", "submission_status_date": "19781221", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling" }, { "submission_type": "SUPPL", "submission_number": "50", "submission_status": "AP", "submission_status_date": "19870519", "review_priority": "PRIORITY", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "28", "submission_status": "AP", "submission_status_date": "19760428", "review_priority": "PRIORITY", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "42", "submission_status": "AP", "submission_status_date": "19810818", "review_priority": "PRIORITY", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "34", "submission_status": "AP", "submission_status_date": "19780627", "review_priority": "PRIORITY", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "40", "submission_status": "AP", "submission_status_date": "19810729", "review_priority": "PRIORITY", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "32", "submission_status": "AP", "submission_status_date": "19780407", "review_priority": "PRIORITY", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "ORIG", "submission_number": "1", "submission_status": "AP", "submission_status_date": "19671106", "review_priority": "PRIORITY", "submission_class_code": "TYPE 1", "submission_class_code_description": "Type 1 - New Molecular Entity" }, { "submission_type": "SUPPL", "submission_number": "30", "submission_status": "AP", "submission_status_date": "19770513", "review_priority": "PRIORITY", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "57", "submission_status": "AP", "submission_status_date": "20030206", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "10882", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/16320slr057_Myambutol_lbl.pdf", "date": "20030206", "type": "Label" }, { "id": "12985", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/16320slr057,058ltr.pdf", "date": "20030206", "type": "Letter" } ] }, { "submission_type": "SUPPL", "submission_number": "49", "submission_status": "AP", "submission_status_date": "19860103", "review_priority": "PRIORITY", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "63", "submission_status": "AP", "submission_status_date": "20081030", "submission_public_notes": "Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.", "review_priority": "STANDARD", "submission_class_code": "LABELING", "submission_class_code_description": "Labeling", "application_docs": [ { "id": "439", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/016320s063ltr.pdf", "date": "20081103", "type": "Letter" }, { "id": "10883", "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016320s063lbl.pdf", "date": "20081107", "type": "Label" } ] }, { "submission_type": "SUPPL", "submission_number": "55", "submission_status": "AP", "submission_status_date": "19980514", "review_priority": "PRIORITY", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "47", "submission_status": "AP", "submission_status_date": "19850912", "review_priority": "PRIORITY", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "39", "submission_status": "AP", "submission_status_date": "19810109", "review_priority": "PRIORITY", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "53", "submission_status": "AP", "submission_status_date": "19950620", "review_priority": "PRIORITY", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "37", "submission_status": "AP", "submission_status_date": "19790403", "review_priority": "PRIORITY", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "51", "submission_status": "AP", "submission_status_date": "19871123", "review_priority": "PRIORITY", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "29", "submission_status": "AP", "submission_status_date": "19760610", "review_priority": "PRIORITY", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "43", "submission_status": "AP", "submission_status_date": "19811103", "review_priority": "PRIORITY", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" }, { "submission_type": "SUPPL", "submission_number": "35", "submission_status": "AP", "submission_status_date": "19780626", "review_priority": "PRIORITY", "submission_class_code": "MANUF (CMC)", "submission_class_code_description": "Manufacturing (CMC)" } ], "application_number": "NDA016320", "sponsor_name": "KANCHAN HLTHCARE", "openfda": { "application_number": [ "NDA016320" ], "brand_name": [ "ETHAMBUTOL HYDROCHLORIDE" ], "generic_name": [ "ETHAMBUTOL HYDROCHLORIDE" ], "manufacturer_name": [ "Marlex Pharmaceuticals, Inc.", "Kanchan Healthcare Inc", "STI Pharma LLC" ], "product_ndc": [ "10135-796", "10135-797", "85742-005", "85742-006", "54879-001", "54879-002" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ETHAMBUTOL HYDROCHLORIDE" ], "rxcui": [ "995599", "995607" ], "spl_id": [ "2dcb6b41-b9a8-4dde-8248-334d13f87a29", "2a57c753-d5e5-4479-845b-614c928d6dc5", "5115f4a9-63ad-ebc3-e063-6294a90a7ba8" ], "spl_set_id": [ "1b9fbe16-edfc-44b6-b8d8-5c5a9d7558e1", "e4ccab0e-84ff-447f-82ca-fa0a3989f6b7", "3f6428d6-3745-4337-ad78-ebfff9f49135" ], "package_ndc": [ "10135-796-01", "10135-797-01", "85742-006-04", "85742-005-04", "54879-002-01", "54879-001-01" ], "unii": [ "QE4VW5FO07" ] }, "products": [ { "product_number": "002", "reference_drug": "No", "brand_name": "MYAMBUTOL", "active_ingredients": [ { "name": "ETHAMBUTOL HYDROCHLORIDE", "strength": "200MG" } ], "reference_standard": "No", "dosage_form": "TABLET", "route": "ORAL", "marketing_status": "Discontinued" }, { "product_number": "003", "reference_drug": "Yes", "brand_name": "MYAMBUTOL", "active_ingredients": [ { "name": "ETHAMBUTOL HYDROCHLORIDE", "strength": "400MG" } ], "reference_standard": "Yes", "dosage_form": "TABLET", "route": "ORAL", "marketing_status": "Prescription", "te_code": "AB" }, { "product_number": "001", "reference_drug": "Yes", "brand_name": "MYAMBUTOL", "active_ingredients": [ { "name": "ETHAMBUTOL HYDROCHLORIDE", "strength": "100MG" } ], "reference_standard": "No", "dosage_form": "TABLET", "route": "ORAL", "marketing_status": "Prescription", "te_code": "AB" }, { "product_number": "004", "reference_drug": "No", "brand_name": "MYAMBUTOL", "active_ingredients": [ { "name": "ETHAMBUTOL HYDROCHLORIDE", "strength": "500MG" } ], "reference_standard": "No", "dosage_form": "TABLET", "route": "ORAL", "marketing_status": "Discontinued" } ] } ] }