What is the endpoint for [B019] Drug approval information?

The [B019] Drug approval information endpoint is GET https://connect.patsnap.com/synapse/drug/approval.

What data can [B019] Drug approval information return?

[B019] Drug approval information Obtain drug approval information about product, submission, etc. See the Response Schema and Success Response Example on this page for the full structure.

Where can I find the OpenAPI schema for [B019] Drug approval information?

The OpenAPI schema is available at /openapi.json#/paths/~1synapse~1drug~1approval/get. You can also browse the full specification at /openapi.json.

[B019] Drug approval information

get

https://connect.patsnap.com/synapse/drug/approval

Try in Sandbox

Obtain drug approval information about product, submission, etc.

Request Parameters

List of parameters supported by this API endpoint

Name	Type	Example	Description
`drug_id` Required	`string`	`68431d4745744d9e9e17a3073edd3920`	Drug ID, obtain this through the drug search interface or drug autocomplete interface

Response Schema

Structure of the API response data

Field Name	Type	Example	Description
`data`	`object`	-	response data
`ema`	`object`	`Please check the form:DrugApprovalEmaDto`	EMA
`products`	`array`	`Please check the form:ApprovalProductDto`	Product Basic Info
`appl_no`	`string`	`125057`	FDA Application ID
`generic`	`integer<int32>`	-	Generic, 0: No, 1: Yes
`strength`	`string`	`40MG/0.8ML`	Strength
`appl_type`	`string`	`BLA`	Application Type
`pack_size`	`string`	`25854e08d0e9858e89ad4438028589d2`	Package Size
`biosimilar`	`integer<int32>`	-	Biosimilar, 0: No, 1: Yes
`product_no`	`string`	`25854e08d0e9858e89ad4438028589d2`	EMA Production Number
`trade_name`	`array`	`[ { "lang": "EN", "name": "HUMIRA" } ]`	Trade Name
`lang`	`string`	`EN`	Language
`name`	`string`	`Ranibizumab (Genentech)`	Drug,Target,Organization,Disease,Country/Location,DICT,Mechanism Action Name
`data_source`	`string`	`FDA_CDER`	Data Source
`approval_date`	`integer<int64>`	`25854e08d0e9858e89ad4438028589d2`	Approval Date
`market_status`	`object`	`{ "display_name": [ { "lang": "EN", "name": "Approved" }, { "lang": "CN", "name": "批准上市" } ], "normalized_id": "42d0efa0fd1a48aea4913755067bc043" }`	Market Status
`display_name`	`array`	`[ { "lang": "EN", "name": "Autologous CAR-T" }, { "lang": "CN", "name": "自体CAR-T" } ]`	Dict Name
`normalized_id`	`string`	`2fbfdb3e92d942c48cbb0adb79f23526`	Dict ID
`special_review`	`array`	`[ { "display_name": [ { "lang": "EN", "name": "Additional Monitoring" }, { "lang": "CN", "name": "额外监测" } ], "normalized_id": "30ffad249563481eb8fcfe4a7342269a" } ]`	Special Review
`applicant_holder`	`array`	`[ { "display_name": [ { "lang": "EN", "name": "AbbVie, Inc." } ], "organization_id": "d88590e686ad5608bbbfeb811b14d188" } ]`	Organization
`display_name`	`array`	`[ { "lang": "EN", "name": "Roche Holding AG" }, { "lang": "CN", "name": "罗氏" } ]`	Organization Name, Referencing "CommonName"
`organization_id`	`string`	`87bfaf037f8e60c9e25595cd98bb27e4`	Organization ID
`drug_approval_id`	`string`	`25854e08d0e9858e89ad4438028589d2`	Drug Approval Id
`last_update_date`	`integer<int64>`	`1722384000000`	Last Update
`first_approval_date`	`integer<int64>`	`25854e08d0e9858e89ad4438028589d2`	First Approval Date
`product_data_source`	`array`	`[ { "lang": "EN", "name": "Orange Book" }, { "lang": "CN", "name": "橙皮书" } ]`	Product Data Source
`product_presentation`	`string`	`Blister (PVC/PE/PVDC/alu)`	Package Type
`content_concentration`	`string`	`0.8 ml (40 mg/0.8 ml)`	Volume
`dosage_form_and_route`	`object`	`Please check the form:ApprovalSubmissionDto`	Dosage Form & Route
`route`	`array`	`[ { "display_name": [ { "lang": "EN", "name": "Subcutaneous" }, { "lang": "CN", "name": "皮下注射" } ], "normalized_id": "6e0ca63bc1734b7aa1ad7a4c846fb4ac" } ]`	Route
`dosage_from`	`array`	`[ { "display_name": [ { "lang": "EN", "name": "Injection" }, { "lang": "CN", "name": "注射剂" } ], "normalized_id": "699243160d8d4fd8aa67da7ff18f90a9" } ]`	Dosage Form
`original_name`	`string`	`Injection; Subcutaneous`	Original Name
`submissions`	`array`	`Please check the form:ApprovalSubmissionDto`	Submission Basic Info
`disease`	`array`	`[ { "disease_id": "e6ee5660ea1d44ad8edb142046da866f", "display_name": [ { "lang": "EN", "name": "Enthesitis-Related Arthritis" }, { "lang": "CN", "name": "附着点炎相关关节炎" } ] } ]`	Indication
`disease_id`	`string`	`06a9082fe1ec4c97bea31d888b9cfdce`	Disease ID
`display_name`	`array`	`[ { "lang": "EN", "name": "Uveitic Macular Edema" }, { "lang": "CN", "name": "葡萄膜炎黄斑水肿" } ]`	Disease Name, Referencing "CommonName"
`regulation`	`array`	`STANDARD; Orphan`	Approval Category
`action_date`	`integer<int64>`	`1698969600000`	EMA Approval Date
`action_type`	`string`	`Approval`	Result
`approval_date`	`integer<int64>`	`1698969600000`	FDA Approval Date
`market_status`	`object`	`{ "display_name": [ { "lang": "EN", "name": "Approved" }, { "lang": "CN", "name": "批准上市" } ], "normalized_id": "42d0efa0fd1a48aea4913755067bc043" }`	Market Status
`submission_no`	`integer<int64>`	`423`	Submission No
`submission_type`	`string`	`SUPPL`	Submission Type
`drug_approval_id`	`string`	`25854e08d0e9858e89ad4438028589d2`	Drug Approval Id
`original_regulation`	`string`	`STANDARD; Orphan`	Approval Category Original Value
`submission_classification`	`string`	`Labeling`	Registration Category
`fda`	`object`	`Please check the form:DrugApprovalFdaDto`	FDA
`products`	`array`	`Please check the form:ApprovalProductDto`	Product Basic Info
`submissions`	`array`	`Please check the form:ApprovalSubmissionDto`	Submission Basic Info
`nmpa`	`object`	`Please check the form:DrugApprovalNmpaDto`	NMPA
`products`	`array`	`Please check the form:ApprovalProductDto`	Product Basic Info
`pmda`	`object`	`Please check the form:DrugApprovalPmdaDto`	PMDA
`products`	`array`	`Please check the form:ApprovalProductDto`	Product Basic Info
`status` Required	`boolean`	`false`	Status
`error_msg`	`string`	`The request parameter format is incorrect！`	Error Message
`error_code` Required	`integer`	`0`	Error Code

Success Response Example

Example of a successful API response

JSON

{
  "data": {
    "ema": {
      "products": [
        {
          "appl_no": 125057,
          "generic": 0,
          "strength": "40MG/0.8ML",
          "appl_type": "BLA",
          "pack_size": "25854e08d0e9858e89ad4438028589d2",
          "biosimilar": 0,
          "product_no": "25854e08d0e9858e89ad4438028589d2",
          "trade_name": [
            {
              "lang": "EN",
              "name": "Ranibizumab (Genentech)"
            }
          ],
          "data_source": "FDA_CDER",
          "approval_date": "25854e08d0e9858e89ad4438028589d2",
          "market_status": {
            "display_name": [
              {
                "lang": "EN",
                "name": "Ranibizumab (Genentech)"
              }
            ],
            "normalized_id": "2fbfdb3e92d942c48cbb0adb79f23526"
          },
          "special_review": [
            {
              "display_name": [
                {
                  "lang": "EN",
                  "name": "Ranibizumab (Genentech)"
                }
              ],
              "normalized_id": "2fbfdb3e92d942c48cbb0adb79f23526"
            }
          ],
          "applicant_holder": [
            {
              "display_name": [
                {
                  "lang": "EN",
                  "name": "Ranibizumab (Genentech)"
                }
              ],
              "organization_id": "87bfaf037f8e60c9e25595cd98bb27e4"
            }
          ],
          "drug_approval_id": "25854e08d0e9858e89ad4438028589d2",
          "last_update_date": 1722384000000,
          "first_approval_date": "25854e08d0e9858e89ad4438028589d2",
          "product_data_source": [
            {
              "lang": "EN",
              "name": "Ranibizumab (Genentech)"
            }
          ],
          "product_presentation": "Blister (PVC/PE/PVDC/alu)",
          "content_concentration": "0.8 ml (40 mg/0.8 ml)",
          "dosage_form_and_route": {
            "route": [
              {
                "display_name": [
                  {
                    "lang": "EN",
                    "name": "Ranibizumab (Genentech)"
                  }
                ],
                "normalized_id": "2fbfdb3e92d942c48cbb0adb79f23526"
              }
            ],
            "dosage_from": [
              {
                "display_name": [
                  {
                    "lang": "EN",
                    "name": "Ranibizumab (Genentech)"
                  }
                ],
                "normalized_id": "2fbfdb3e92d942c48cbb0adb79f23526"
              }
            ],
            "original_name": "Injection; Subcutaneous"
          }
        }
      ],
      "submissions": [
        {
          "disease": [
            {
              "disease_id": "06a9082fe1ec4c97bea31d888b9cfdce",
              "display_name": [
                {
                  "lang": "EN",
                  "name": "Ranibizumab (Genentech)"
                }
              ]
            }
          ],
          "regulation": [
            {
              "display_name": [
                {
                  "lang": "EN",
                  "name": "Ranibizumab (Genentech)"
                }
              ],
              "normalized_id": "2fbfdb3e92d942c48cbb0adb79f23526"
            }
          ],
          "action_date": 1698969600000,
          "action_type": "Approval",
          "approval_date": 1698969600000,
          "market_status": {
            "display_name": [
              {
                "lang": "EN",
                "name": "Ranibizumab (Genentech)"
              }
            ],
            "normalized_id": "2fbfdb3e92d942c48cbb0adb79f23526"
          },
          "submission_no": 423,
          "submission_type": "SUPPL",
          "drug_approval_id": "25854e08d0e9858e89ad4438028589d2",
          "original_regulation": "STANDARD; Orphan",
          "submission_classification": "Labeling"
        }
      ]
    },
    "fda": {
      "products": [
        {
          "appl_no": 125057,
          "generic": 0,
          "strength": "40MG/0.8ML",
          "appl_type": "BLA",
          "pack_size": "25854e08d0e9858e89ad4438028589d2",
          "biosimilar": 0,
          "product_no": "25854e08d0e9858e89ad4438028589d2",
          "trade_name": [
            {
              "lang": "EN",
              "name": "Ranibizumab (Genentech)"
            }
          ],
          "data_source": "FDA_CDER",
          "approval_date": "25854e08d0e9858e89ad4438028589d2",
          "market_status": {
            "display_name": [
              {
                "lang": "EN",
                "name": "Ranibizumab (Genentech)"
              }
            ],
            "normalized_id": "2fbfdb3e92d942c48cbb0adb79f23526"
          },
          "special_review": [
            {
              "display_name": [
                {
                  "lang": "EN",
                  "name": "Ranibizumab (Genentech)"
                }
              ],
              "normalized_id": "2fbfdb3e92d942c48cbb0adb79f23526"
            }
          ],
          "applicant_holder": [
            {
              "display_name": [
                {
                  "lang": "EN",
                  "name": "Ranibizumab (Genentech)"
                }
              ],
              "organization_id": "87bfaf037f8e60c9e25595cd98bb27e4"
            }
          ],
          "drug_approval_id": "25854e08d0e9858e89ad4438028589d2",
          "last_update_date": 1722384000000,
          "first_approval_date": "25854e08d0e9858e89ad4438028589d2",
          "product_data_source": [
            {
              "lang": "EN",
              "name": "Ranibizumab (Genentech)"
            }
          ],
          "product_presentation": "Blister (PVC/PE/PVDC/alu)",
          "content_concentration": "0.8 ml (40 mg/0.8 ml)",
          "dosage_form_and_route": {
            "route": [
              {
                "display_name": [
                  {
                    "lang": "EN",
                    "name": "Ranibizumab (Genentech)"
                  }
                ],
                "normalized_id": "2fbfdb3e92d942c48cbb0adb79f23526"
              }
            ],
            "dosage_from": [
              {
                "display_name": [
                  {
                    "lang": "EN",
                    "name": "Ranibizumab (Genentech)"
                  }
                ],
                "normalized_id": "2fbfdb3e92d942c48cbb0adb79f23526"
              }
            ],
            "original_name": "Injection; Subcutaneous"
          }
        }
      ],
      "submissions": [
        {
          "disease": [
            {
              "disease_id": "06a9082fe1ec4c97bea31d888b9cfdce",
              "display_name": [
                {
                  "lang": "EN",
                  "name": "Ranibizumab (Genentech)"
                }
              ]
            }
          ],
          "regulation": [
            {
              "display_name": [
                {
                  "lang": "EN",
                  "name": "Ranibizumab (Genentech)"
                }
              ],
              "normalized_id": "2fbfdb3e92d942c48cbb0adb79f23526"
            }
          ],
          "action_date": 1698969600000,
          "action_type": "Approval",
          "approval_date": 1698969600000,
          "market_status": {
            "display_name": [
              {
                "lang": "EN",
                "name": "Ranibizumab (Genentech)"
              }
            ],
            "normalized_id": "2fbfdb3e92d942c48cbb0adb79f23526"
          },
          "submission_no": 423,
          "submission_type": "SUPPL",
          "drug_approval_id": "25854e08d0e9858e89ad4438028589d2",
          "original_regulation": "STANDARD; Orphan",
          "submission_classification": "Labeling"
        }
      ]
    },
    "nmpa": {
      "products": [
        {
          "appl_no": 125057,
          "generic": 0,
          "strength": "40MG/0.8ML",
          "appl_type": "BLA",
          "pack_size": "25854e08d0e9858e89ad4438028589d2",
          "biosimilar": 0,
          "product_no": "25854e08d0e9858e89ad4438028589d2",
          "trade_name": [
            {
              "lang": "EN",
              "name": "Ranibizumab (Genentech)"
            }
          ],
          "data_source": "FDA_CDER",
          "approval_date": "25854e08d0e9858e89ad4438028589d2",
          "market_status": {
            "display_name": [
              {
                "lang": "EN",
                "name": "Ranibizumab (Genentech)"
              }
            ],
            "normalized_id": "2fbfdb3e92d942c48cbb0adb79f23526"
          },
          "special_review": [
            {
              "display_name": [
                {
                  "lang": "EN",
                  "name": "Ranibizumab (Genentech)"
                }
              ],
              "normalized_id": "2fbfdb3e92d942c48cbb0adb79f23526"
            }
          ],
          "applicant_holder": [
            {
              "display_name": [
                {
                  "lang": "EN",
                  "name": "Ranibizumab (Genentech)"
                }
              ],
              "organization_id": "87bfaf037f8e60c9e25595cd98bb27e4"
            }
          ],
          "drug_approval_id": "25854e08d0e9858e89ad4438028589d2",
          "last_update_date": 1722384000000,
          "first_approval_date": "25854e08d0e9858e89ad4438028589d2",
          "product_data_source": [
            {
              "lang": "EN",
              "name": "Ranibizumab (Genentech)"
            }
          ],
          "product_presentation": "Blister (PVC/PE/PVDC/alu)",
          "content_concentration": "0.8 ml (40 mg/0.8 ml)",
          "dosage_form_and_route": {
            "route": [
              {
                "display_name": [
                  {
                    "lang": "EN",
                    "name": "Ranibizumab (Genentech)"
                  }
                ],
                "normalized_id": "2fbfdb3e92d942c48cbb0adb79f23526"
              }
            ],
            "dosage_from": [
              {
                "display_name": [
                  {
                    "lang": "EN",
                    "name": "Ranibizumab (Genentech)"
                  }
                ],
                "normalized_id": "2fbfdb3e92d942c48cbb0adb79f23526"
              }
            ],
            "original_name": "Injection; Subcutaneous"
          }
        }
      ]
    },
    "pmda": {
      "products": [
        {
          "appl_no": 125057,
          "generic": 0,
          "strength": "40MG/0.8ML",
          "appl_type": "BLA",
          "pack_size": "25854e08d0e9858e89ad4438028589d2",
          "biosimilar": 0,
          "product_no": "25854e08d0e9858e89ad4438028589d2",
          "trade_name": [
            {
              "lang": "EN",
              "name": "Ranibizumab (Genentech)"
            }
          ],
          "data_source": "FDA_CDER",
          "approval_date": "25854e08d0e9858e89ad4438028589d2",
          "market_status": {
            "display_name": [
              {
                "lang": "EN",
                "name": "Ranibizumab (Genentech)"
              }
            ],
            "normalized_id": "2fbfdb3e92d942c48cbb0adb79f23526"
          },
          "special_review": [
            {
              "display_name": [
                {
                  "lang": "EN",
                  "name": "Ranibizumab (Genentech)"
                }
              ],
              "normalized_id": "2fbfdb3e92d942c48cbb0adb79f23526"
            }
          ],
          "applicant_holder": [
            {
              "display_name": [
                {
                  "lang": "EN",
                  "name": "Ranibizumab (Genentech)"
                }
              ],
              "organization_id": "87bfaf037f8e60c9e25595cd98bb27e4"
            }
          ],
          "drug_approval_id": "25854e08d0e9858e89ad4438028589d2",
          "last_update_date": 1722384000000,
          "first_approval_date": "25854e08d0e9858e89ad4438028589d2",
          "product_data_source": [
            {
              "lang": "EN",
              "name": "Ranibizumab (Genentech)"
            }
          ],
          "product_presentation": "Blister (PVC/PE/PVDC/alu)",
          "content_concentration": "0.8 ml (40 mg/0.8 ml)",
          "dosage_form_and_route": {
            "route": [
              {
                "display_name": [
                  {
                    "lang": "EN",
                    "name": "Ranibizumab (Genentech)"
                  }
                ],
                "normalized_id": "2fbfdb3e92d942c48cbb0adb79f23526"
              }
            ],
            "dosage_from": [
              {
                "display_name": [
                  {
                    "lang": "EN",
                    "name": "Ranibizumab (Genentech)"
                  }
                ],
                "normalized_id": "2fbfdb3e92d942c48cbb0adb79f23526"
              }
            ],
            "original_name": "Injection; Subcutaneous"
          }
        }
      ]
    }
  },
  "status": true,
  "error_code": 0
}

Error Codes

List of possible error codes returned by this endpoint

Business Errors

Error Code	Description
`68300004`	Invalid parameter!
`68300005`	Search api failure!
`68300006`	Analytic basic access error!
`68300007`	Bad request!
`68300008`	Service error, please try again later!
`68300010`	The file does not comply with upload specifications!

Platform Errors

Error Code	Description
`67200001`	API call exceeds the total limit set by the platform!
`67200002`	Quota exceeds the limit!
`67200003`	Access token expired or authentication error!
`67200004`	No permission or API package quota has exceeded the limit!
`67200005`	Insufficient balance, call failed!
`67200006`	This client has expired and call failed!
`67200007`	Exceeded the call limit, call failed!

HTTP Status Codes

Status Code	Description
`0`	Success
`401`	Unauthorized
`403`	Forbidden
`404`	Not Found

Performance Metrics

Expected performance characteristics for this endpoint

Normal Response Time

5000 ms

Max Response Time

10000 ms