{
  "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": "2026-07-10",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "submissions": [
        {
          "submission_type": "SUPPL",
          "submission_number": "11",
          "submission_status": "AP",
          "submission_status_date": "19991112",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy",
          "application_docs": [
            {
              "id": "21111",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20076S11LTR.PDF",
              "date": "19991112",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "38",
          "submission_status": "AP",
          "submission_status_date": "20160119",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "36",
          "submission_status": "AP",
          "submission_status_date": "20140725",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "12182",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020076Orig1s036lbl.pdf",
              "date": "20140729",
              "type": "Label"
            },
            {
              "id": "21117",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020076Orig1s036ltr.pdf",
              "date": "20140728",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "9",
          "submission_status": "AP",
          "submission_status_date": "19960724",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "28",
          "submission_status": "AP",
          "submission_status_date": "20051122",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "1992",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020076s028ltr.pdf",
              "date": "20051130",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "42",
          "submission_status": "AP",
          "submission_status_date": "20160706",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "12184",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020076Orig1s042lbl.pdf",
              "date": "20160708",
              "type": "Label"
            },
            {
              "id": "1993",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020076Orig1s042ltr.pdf",
              "date": "20160707",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "7",
          "submission_status": "AP",
          "submission_status_date": "19960208",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "40",
          "submission_status": "AP",
          "submission_status_date": "20160509",
          "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": "20001107",
          "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": "20040206",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "21113",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20076slr024ltr.pdf",
              "date": "20040303",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "3",
          "submission_status": "AP",
          "submission_status_date": "19920721",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "19920106",
          "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": "19981029",
          "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": "20020712",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "1991",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20076slr020ltr.pdf",
              "date": "20020712",
              "type": "Letter"
            },
            {
              "id": "34239",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20076s20lbl.pdf",
              "date": "20020712",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "10",
          "submission_status": "AP",
          "submission_status_date": "19951006",
          "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": "20180627",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "54847",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020076Orig1s049ltr.pdf",
              "date": "20180706",
              "type": "Letter"
            },
            {
              "id": "54863",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020076Orig1s049lbl.pdf",
              "date": "20180706",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "39",
          "submission_status": "AP",
          "submission_status_date": "20160404",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "45",
          "submission_status": "AP",
          "submission_status_date": "20170723",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "49081",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020076Orig1s045ltr.pdf",
              "date": "20170725",
              "type": "Letter"
            },
            {
              "id": "49085",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020076Orig1s045lbl.pdf",
              "date": "20170726",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "ORIG",
          "submission_number": "1",
          "submission_status": "AP",
          "submission_status_date": "19911127",
          "review_priority": "STANDARD",
          "submission_class_code": "TYPE 3",
          "submission_class_code_description": "Type 3 - New Dosage Form"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "37",
          "submission_status": "AP",
          "submission_status_date": "20151117",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "51",
          "submission_status": "AP",
          "submission_status_date": "20190102",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "57115",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020076Orig1s051ltr.pdf",
              "date": "20190201",
              "type": "Letter"
            },
            {
              "id": "57116",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020076Orig1s051lbl.pdf",
              "date": "20190104",
              "type": "Label"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "29",
          "submission_status": "AP",
          "submission_status_date": "20060505",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "21116",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020076s029ltr.pdf",
              "date": "20060516",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "43",
          "submission_status": "AP",
          "submission_status_date": "20160705",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "12185",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020076Orig1s043lbl.pdf",
              "date": "20160718",
              "type": "Label"
            },
            {
              "id": "21119",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020076Orig1s043ltr.pdf",
              "date": "20160707",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "35",
          "submission_status": "AP",
          "submission_status_date": "20130516",
          "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": "20041021",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)",
          "application_docs": [
            {
              "id": "21115",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20076s027ltr.pdf",
              "date": "20041029",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "41",
          "submission_status": "AP",
          "submission_status_date": "20160510",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "12183",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/20076Orig1s041Lbl.pdf",
              "date": "20160617",
              "type": "Label"
            },
            {
              "id": "21118",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020076Orig1s041ltr.pdf",
              "date": "20160516",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "6",
          "submission_status": "AP",
          "submission_status_date": "19941006",
          "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": "20040121",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "21114",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20076slr025ltr.pdf",
              "date": "20040122",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "17",
          "submission_status": "AP",
          "submission_status_date": "20000131",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "4",
          "submission_status": "AP",
          "submission_status_date": "19920721",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "15",
          "submission_status": "AP",
          "submission_status_date": "19991203",
          "review_priority": "STANDARD",
          "submission_class_code": "MANUF (CMC)",
          "submission_class_code_description": "Manufacturing (CMC)"
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "21",
          "submission_status": "AP",
          "submission_status_date": "20020715",
          "review_priority": "STANDARD",
          "submission_class_code": "LABELING",
          "submission_class_code_description": "Labeling",
          "application_docs": [
            {
              "id": "12181",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20076s21lbl.pdf",
              "date": "20020715",
              "type": "Label"
            },
            {
              "id": "21112",
              "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20076slr021ltr.pdf",
              "date": "20020715",
              "type": "Letter"
            }
          ]
        },
        {
          "submission_type": "SUPPL",
          "submission_number": "13",
          "submission_status": "AP",
          "submission_status_date": "19990107",
          "review_priority": "STANDARD",
          "submission_class_code": "EFFICACY",
          "submission_class_code_description": "Efficacy"
        }
      ],
      "application_number": "NDA020076",
      "sponsor_name": "DR REDDYS LABS SA",
      "openfda": {
        "application_number": [
          "NDA020076"
        ],
        "brand_name": [
          "NICOTINE TRANSDERMAL SYSTEM",
          "NICOTINE TRANSDERMAL SYSTEM STEP 3",
          "NICOTINE TRANSDERMAL SYSTEM STEP 2",
          "NICOTINE TRANSDERMAL SYSTEM STEP 1",
          "NICOTINE TRANSDERMAL SYSTEM PATCH STEP 3",
          "NICOTINE TRANSDERMAL SYSTEM PATCH STEP 2",
          "NICOTINE TRANSDERMAL SYSTEM PATCH STEP 1",
          "HABITROL STEP 3",
          "HABITROL STEP 2",
          "HABITROL STEP 1"
        ],
        "generic_name": [
          "NICOTINE",
          "NICOTINE TRANSDERMAL SYSTEM PATCH"
        ],
        "manufacturer_name": [
          "Dr. Reddys Laboratories Inc.",
          "Rugby Laboratories",
          "BluePoint Laboratories",
          "Dr. Reddy's Laboratories Inc.",
          "AmerisourceBergen Drug Corporation",
          "CARDINAL HEALTH 110, LLC. DBA LEADER"
        ],
        "product_ndc": [
          "43598-445",
          "0536-1106",
          "0536-1108",
          "0536-1107",
          "68001-697",
          "68001-699",
          "68001-698",
          "55741-449",
          "43598-446",
          "43598-448",
          "43598-447",
          "46122-831",
          "46122-833",
          "46122-832",
          "70000-0760",
          "70000-0762",
          "70000-0761",
          "55741-446",
          "55741-448",
          "55741-447"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "TRANSDERMAL"
        ],
        "rxcui": [
          "198029",
          "198030",
          "198031",
          "892244",
          "207712",
          "207716",
          "207734"
        ],
        "spl_id": [
          "8dd0ce2f-82c4-2685-3981-fa22b64b3208",
          "4db08daa-369f-52ce-4876-e03455838521",
          "563efbee-122d-62d6-e063-6394a90a2a2b",
          "bed562f2-f5b3-632b-4b2c-fdf34a061098",
          "15710e2c-e365-1726-06de-fb172f976a3b",
          "e285aba0-38e4-e3f9-90f5-b62b4191f61e",
          "2ffcf657-7e4f-d67f-1bf7-38bd7fb4946a",
          "7b8f92dc-a9f4-6c9c-d0ca-bd8f89cbd875"
        ],
        "spl_set_id": [
          "e2391b29-9bac-fc09-f2a5-a3370bc4e2c3",
          "ae406389-0f83-d5c8-bd2f-56075e57453a",
          "4856e99a-badc-b957-e063-6294a90a8606",
          "b9946e3c-80c9-3076-7c32-e2988ac07048",
          "3a68eb70-0548-fa6f-8b1c-375e8799f24f",
          "e51d2c09-a20f-eb9b-e3e4-013f3e488ab3",
          "dbbed17b-8ad3-05fb-fb63-03fbb75eae05",
          "051be7ae-6504-c2d8-7424-2e328e4fcfc2"
        ],
        "package_ndc": [
          "43598-445-56",
          "0536-1108-88",
          "0536-1108-71",
          "0536-1108-52",
          "0536-1107-88",
          "0536-1107-52",
          "0536-1106-88",
          "0536-1106-52",
          "68001-699-90",
          "68001-699-88",
          "68001-699-91",
          "68001-698-90",
          "68001-698-88",
          "68001-697-90",
          "68001-697-88",
          "55741-449-56",
          "43598-448-74",
          "43598-448-28",
          "43598-448-70",
          "43598-447-74",
          "43598-447-70",
          "43598-446-74",
          "43598-446-70",
          "46122-833-45",
          "46122-833-75",
          "46122-833-76",
          "46122-832-45",
          "46122-831-45",
          "70000-0762-1",
          "70000-0762-2",
          "70000-0761-1",
          "70000-0761-2",
          "70000-0760-1",
          "70000-0760-2",
          "55741-448-74",
          "55741-448-70",
          "55741-448-28",
          "55741-447-74",
          "55741-447-70",
          "55741-446-74",
          "55741-446-70"
        ],
        "substance_name": [
          "NICOTINE"
        ],
        "nui": [
          "N0000175706",
          "M0014836"
        ],
        "pharm_class_epc": [
          "Cholinergic Nicotinic Agonist [EPC]"
        ],
        "pharm_class_cs": [
          "Nicotine [CS]"
        ],
        "unii": [
          "6M3C89ZY6R"
        ]
      },
      "products": [
        {
          "product_number": "004",
          "reference_drug": "Yes",
          "brand_name": "HABITROL",
          "active_ingredients": [
            {
              "name": "NICOTINE",
              "strength": "7MG/24HR"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "FILM, EXTENDED RELEASE",
          "route": "TRANSDERMAL",
          "marketing_status": "Over-the-counter"
        },
        {
          "product_number": "002",
          "reference_drug": "No",
          "brand_name": "HABITROL",
          "active_ingredients": [
            {
              "name": "NICOTINE",
              "strength": "14MG/24HR"
            }
          ],
          "dosage_form": "Film, Extended Release",
          "route": "Transdermal",
          "marketing_status": "Discontinued"
        },
        {
          "product_number": "005",
          "reference_drug": "Yes",
          "brand_name": "HABITROL",
          "active_ingredients": [
            {
              "name": "NICOTINE",
              "strength": "14MG/24HR"
            }
          ],
          "reference_standard": "No",
          "dosage_form": "FILM, EXTENDED RELEASE",
          "route": "TRANSDERMAL",
          "marketing_status": "Over-the-counter"
        },
        {
          "product_number": "003",
          "reference_drug": "No",
          "brand_name": "HABITROL",
          "active_ingredients": [
            {
              "name": "NICOTINE",
              "strength": "21MG/24HR"
            }
          ],
          "dosage_form": "Film, Extended Release",
          "route": "Transdermal",
          "marketing_status": "Discontinued"
        },
        {
          "product_number": "001",
          "reference_drug": "No",
          "brand_name": "HABITROL",
          "active_ingredients": [
            {
              "name": "NICOTINE",
              "strength": "7MG/24HR"
            }
          ],
          "dosage_form": "Film, Extended Release",
          "route": "Transdermal",
          "marketing_status": "Discontinued"
        },
        {
          "product_number": "006",
          "reference_drug": "Yes",
          "brand_name": "HABITROL",
          "active_ingredients": [
            {
              "name": "NICOTINE",
              "strength": "21MG/24HR"
            }
          ],
          "reference_standard": "Yes",
          "dosage_form": "FILM, EXTENDED RELEASE",
          "route": "TRANSDERMAL",
          "marketing_status": "Over-the-counter"
        }
      ]
    }
  ]
}