Drug Basic Data
B019 Drug approval information
Obtain drug approval information about product, submission, etc.
get/synapse/drug/approval
Request
- Base URLhttps://connect.patsnap.com
- AuthHTTP bearer
- TypeScriptA function with typed inputs. Its response is checked against the schema.
Query parameters
drug_idstring required
Drug ID, obtain this through the drug search interface or drug autocomplete interface
Example:68431d4745744d9e9e17a3073edd3920
Response
Successful b019 drug approval information response.
Example response
{
"data": {
"ema": {
"products": [
{
"strength": "40MG/0.8ML",
"appl_type": "BLA",
"pack_size": "25854e08d0e9858e89ad4438028589d2",
"product_no": "25854e08d0e9858e89ad4438028589d2",
"trade_name": [
{
"lang": "EN",
"name": "HUMIRA"
}
],
"data_source": "FDA_CDER",
"market_status": {
"display_name": [
{
"lang": "EN",
"name": "Autologous CAR-T"
},
{
"lang": "CN",
"name": "自体CAR-T"
}
],
"normalized_id": "2fbfdb3e92d942c48cbb0adb79f23526"
},
"special_review": [
{
"display_name": [
{
"lang": "EN",
"name": "Additional Monitoring"
},
{
"lang": "CN",
"name": "额外监测"
}
],
"normalized_id": "30ffad249563481eb8fcfe4a7342269a"
}
],
"applicant_holder": [
{
"display_name": [
{
"lang": "EN",
"name": "AbbVie, Inc."
}
],
"organization_id": "d88590e686ad5608bbbfeb811b14d188"
}
],
"drug_approval_id": "25854e08d0e9858e89ad4438028589d2",
"last_update_date": 1722384000000,
"product_data_source": [
{
"lang": "EN",
"name": "Orange Book"
},
{
"lang": "CN",
"name": "橙皮书"
}
],
"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": "Subcutaneous"
},
{
"lang": "CN",
"name": "皮下注射"
}
],
"normalized_id": "6e0ca63bc1734b7aa1ad7a4c846fb4ac"
}
],
"dosage_from": [
{
"display_name": [
{
"lang": "EN",
"name": "Injection"
},
{
"lang": "CN",
"name": "注射剂"
}
],
"normalized_id": "699243160d8d4fd8aa67da7ff18f90a9"
}
],
"original_name": "Injection; Subcutaneous"
}
}
],
"submissions": [
{
"disease": [
{
"disease_id": "e6ee5660ea1d44ad8edb142046da866f",
"display_name": [
{
"lang": "EN",
"name": "Enthesitis-Related Arthritis"
},
{
"lang": "CN",
"name": "附着点炎相关关节炎"
}
]
}
],
"regulation": [
{
"display_name": [
{
"lang": "EN",
"name": "Autologous CAR-T"
},
{
"lang": "CN",
"name": "自体CAR-T"
}
],
"normalized_id": "2fbfdb3e92d942c48cbb0adb79f23526"
}
],
"action_date": 1698969600000,
"action_type": "Approval",
"approval_date": 1698969600000,
"market_status": {
"display_name": [
{
"lang": "EN",
"name": "Autologous CAR-T"
},
{
"lang": "CN",
"name": "自体CAR-T"
}
],
"normalized_id": "2fbfdb3e92d942c48cbb0adb79f23526"
},
"submission_no": 423,
"submission_type": "SUPPL",
"drug_approval_id": "25854e08d0e9858e89ad4438028589d2",
"original_regulation": "STANDARD; Orphan",
"submission_classification": "Labeling"
}
]
},
"fda": {
"products": [
{
"strength": "40MG/0.8ML",
"appl_type": "BLA",
"pack_size": "25854e08d0e9858e89ad4438028589d2",
"product_no": "25854e08d0e9858e89ad4438028589d2",
"trade_name": [
{
"lang": "EN",
"name": "HUMIRA"
}
],
"data_source": "FDA_CDER",
"market_status": {
"display_name": [
{
"lang": "EN",
"name": "Autologous CAR-T"
},
{
"lang": "CN",
"name": "自体CAR-T"
}
],
"normalized_id": "2fbfdb3e92d942c48cbb0adb79f23526"
},
"special_review": [
{
"display_name": [
{
"lang": "EN",
"name": "Additional Monitoring"
},
{
"lang": "CN",
"name": "额外监测"
}
],
"normalized_id": "30ffad249563481eb8fcfe4a7342269a"
}
],
"applicant_holder": [
{
"display_name": [
{
"lang": "EN",
"name": "AbbVie, Inc."
}
],
"organization_id": "d88590e686ad5608bbbfeb811b14d188"
}
],
"drug_approval_id": "25854e08d0e9858e89ad4438028589d2",
"last_update_date": 1722384000000,
"product_data_source": [
{
"lang": "EN",
"name": "Orange Book"
},
{
"lang": "CN",
"name": "橙皮书"
}
],
"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": "Subcutaneous"
},
{
"lang": "CN",
"name": "皮下注射"
}
],
"normalized_id": "6e0ca63bc1734b7aa1ad7a4c846fb4ac"
}
],
"dosage_from": [
{
"display_name": [
{
"lang": "EN",
"name": "Injection"
},
{
"lang": "CN",
"name": "注射剂"
}
],
"normalized_id": "699243160d8d4fd8aa67da7ff18f90a9"
}
],
"original_name": "Injection; Subcutaneous"
}
}
],
"submissions": [
{
"disease": [
{
"disease_id": "e6ee5660ea1d44ad8edb142046da866f",
"display_name": [
{
"lang": "EN",
"name": "Enthesitis-Related Arthritis"
},
{
"lang": "CN",
"name": "附着点炎相关关节炎"
}
]
}
],
"regulation": [
{
"display_name": [
{
"lang": "EN",
"name": "Autologous CAR-T"
},
{
"lang": "CN",
"name": "自体CAR-T"
}
],
"normalized_id": "2fbfdb3e92d942c48cbb0adb79f23526"
}
],
"action_date": 1698969600000,
"action_type": "Approval",
"approval_date": 1698969600000,
"market_status": {
"display_name": [
{
"lang": "EN",
"name": "Autologous CAR-T"
},
{
"lang": "CN",
"name": "自体CAR-T"
}
],
"normalized_id": "2fbfdb3e92d942c48cbb0adb79f23526"
},
"submission_no": 423,
"submission_type": "SUPPL",
"drug_approval_id": "25854e08d0e9858e89ad4438028589d2",
"original_regulation": "STANDARD; Orphan",
"submission_classification": "Labeling"
}
]
},
"nmpa": {
"products": [
{
"strength": "40MG/0.8ML",
"appl_type": "BLA",
"pack_size": "25854e08d0e9858e89ad4438028589d2",
"product_no": "25854e08d0e9858e89ad4438028589d2",
"trade_name": [
{
"lang": "EN",
"name": "HUMIRA"
}
],
"data_source": "FDA_CDER",
"market_status": {
"display_name": [
{
"lang": "EN",
"name": "Autologous CAR-T"
},
{
"lang": "CN",
"name": "自体CAR-T"
}
],
"normalized_id": "2fbfdb3e92d942c48cbb0adb79f23526"
},
"special_review": [
{
"display_name": [
{
"lang": "EN",
"name": "Additional Monitoring"
},
{
"lang": "CN",
"name": "额外监测"
}
],
"normalized_id": "30ffad249563481eb8fcfe4a7342269a"
}
],
"applicant_holder": [
{
"display_name": [
{
"lang": "EN",
"name": "AbbVie, Inc."
}
],
"organization_id": "d88590e686ad5608bbbfeb811b14d188"
}
],
"drug_approval_id": "25854e08d0e9858e89ad4438028589d2",
"last_update_date": 1722384000000,
"product_data_source": [
{
"lang": "EN",
"name": "Orange Book"
},
{
"lang": "CN",
"name": "橙皮书"
}
],
"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": "Subcutaneous"
},
{
"lang": "CN",
"name": "皮下注射"
}
],
"normalized_id": "6e0ca63bc1734b7aa1ad7a4c846fb4ac"
}
],
"dosage_from": [
{
"display_name": [
{
"lang": "EN",
"name": "Injection"
},
{
"lang": "CN",
"name": "注射剂"
}
],
"normalized_id": "699243160d8d4fd8aa67da7ff18f90a9"
}
],
"original_name": "Injection; Subcutaneous"
}
}
]
},
"pmda": {
"products": [
{
"strength": "40MG/0.8ML",
"appl_type": "BLA",
"pack_size": "25854e08d0e9858e89ad4438028589d2",
"product_no": "25854e08d0e9858e89ad4438028589d2",
"trade_name": [
{
"lang": "EN",
"name": "HUMIRA"
}
],
"data_source": "FDA_CDER",
"market_status": {
"display_name": [
{
"lang": "EN",
"name": "Autologous CAR-T"
},
{
"lang": "CN",
"name": "自体CAR-T"
}
],
"normalized_id": "2fbfdb3e92d942c48cbb0adb79f23526"
},
"special_review": [
{
"display_name": [
{
"lang": "EN",
"name": "Additional Monitoring"
},
{
"lang": "CN",
"name": "额外监测"
}
],
"normalized_id": "30ffad249563481eb8fcfe4a7342269a"
}
],
"applicant_holder": [
{
"display_name": [
{
"lang": "EN",
"name": "AbbVie, Inc."
}
],
"organization_id": "d88590e686ad5608bbbfeb811b14d188"
}
],
"drug_approval_id": "25854e08d0e9858e89ad4438028589d2",
"last_update_date": 1722384000000,
"product_data_source": [
{
"lang": "EN",
"name": "Orange Book"
},
{
"lang": "CN",
"name": "橙皮书"
}
],
"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": "Subcutaneous"
},
{
"lang": "CN",
"name": "皮下注射"
}
],
"normalized_id": "6e0ca63bc1734b7aa1ad7a4c846fb4ac"
}
],
"dosage_from": [
{
"display_name": [
{
"lang": "EN",
"name": "Injection"
},
{
"lang": "CN",
"name": "注射剂"
}
],
"normalized_id": "699243160d8d4fd8aa67da7ff18f90a9"
}
],
"original_name": "Injection; Subcutaneous"
}
}
]
}
},
"error_msg": "The request parameter format is incorrect！"
}Changes
No recorded changes to this operation across all 1 revision of this API.