---
title: "B019 Drug approval information"
method: GET
path: "/synapse/drug/approval"
tags: ["Drug Basic Data"]
---

# B019 Drug approval information

`GET /synapse/drug/approval`

## Request

- Base URL: `https://connect.patsnap.com`
- URL: `https://connect.patsnap.com/synapse/drug/approval`
- Auth: HTTP bearer
- TypeScript: <https://skmtc.dev/patsnap/apis/patsnap-open-platform-api/docs/synapse/drug/approval/get.ts> (a function with typed inputs; its response is checked against the schema)

Obtain drug approval information about product, submission, etc.

## Query parameters

- `drug_id` string, required: Drug ID, obtain this through the drug search interface or drug autocomplete interface

## Response `200`

Successful b019 drug approval information response.

- B019DrugApprovalResponse
  - `data` B019DrugApprovalGetDrugApprovalResponseDto
    - `ema` B019DrugApprovalDrugApprovalEmaDto
      - `products` B019DrugApprovalApprovalProductDto[]: Product Basic Info
        - `appl_no` string: FDA Application ID
        - `generic` integer: Generic, 0: No, 1: Yes
        - `strength` string: Strength
        - `appl_type` string: Application Type
        - `pack_size` string: Package Size
        - `biosimilar` integer: Biosimilar, 0: No, 1: Yes
        - `product_no` string: EMA Production Number
        - `trade_name` B019DrugApprovalCommonName[]: Trade Name
          - `lang` string: Language
          - `name` string: Drug,Target,Organization,Disease,Country/Location,DICT,Mechanism Action Name
        - `data_source` string: Data Source
        - `approval_date` integer: Approval Date
        - `market_status` B019DrugApprovalCommonDictionary
          - `display_name` B019DrugApprovalCommonName[]: Dict Name
            - `lang` string: Language
            - `name` string: Drug,Target,Organization,Disease,Country/Location,DICT,Mechanism Action Name
          - `normalized_id` string: Dict ID
        - `special_review` B019DrugApprovalCommonDictionary[]: Special Review
          - `display_name` B019DrugApprovalCommonName[]: Dict Name
            - `lang` string: Language
            - `name` string: Drug,Target,Organization,Disease,Country/Location,DICT,Mechanism Action Name
          - `normalized_id` string: Dict ID
        - `applicant_holder` B019DrugApprovalCommonOrganization[]: Organization
          - `display_name` B019DrugApprovalCommonName[]: Organization Name, Referencing "CommonName"
            - `lang` string: Language
            - `name` string: Drug,Target,Organization,Disease,Country/Location,DICT,Mechanism Action Name
          - `organization_id` string: Organization ID
        - `drug_approval_id` string: Drug Approval Id
        - `last_update_date` integer: Last Update
        - `first_approval_date` integer: First Approval Date
        - `product_data_source` B019DrugApprovalCommonName[]: Product Data Source
          - `lang` string: Language
          - `name` string: Drug,Target,Organization,Disease,Country/Location,DICT,Mechanism Action Name
        - `product_presentation` string: Package Type
        - `content_concentration` string: Volume
        - `dosage_form_and_route` B019DrugApprovalDosageFormAndRouteDto
          - `route` B019DrugApprovalCommonDictionary[]: Route
            - `display_name` B019DrugApprovalCommonName[]: Dict Name
              - …
            - `normalized_id` string: Dict ID
          - `dosage_from` B019DrugApprovalCommonDictionary[]: Dosage Form
            - `display_name` B019DrugApprovalCommonName[]: Dict Name
              - …
            - `normalized_id` string: Dict ID
          - `original_name` string: Original Name
      - `submissions` B019DrugApprovalApprovalSubmissionDto[]: Submission Basic Info
        - `disease` B019DrugApprovalCommonDisease[]: Indication
          - `disease_id` string: Disease ID
          - `display_name` B019DrugApprovalCommonName[]: Disease Name, Referencing "CommonName"
            - `lang` string: Language
            - `name` string: Drug,Target,Organization,Disease,Country/Location,DICT,Mechanism Action Name
        - `regulation` B019DrugApprovalCommonDictionary[]: Approval Category
          - `display_name` B019DrugApprovalCommonName[]: Dict Name
            - `lang` string: Language
            - `name` string: Drug,Target,Organization,Disease,Country/Location,DICT,Mechanism Action Name
          - `normalized_id` string: Dict ID
        - `action_date` integer: EMA Approval Date
        - `action_type` string: Result
        - `approval_date` integer: FDA Approval Date
        - `market_status` B019DrugApprovalCommonDictionary
          - `display_name` B019DrugApprovalCommonName[]: Dict Name
            - `lang` string: Language
            - `name` string: Drug,Target,Organization,Disease,Country/Location,DICT,Mechanism Action Name
          - `normalized_id` string: Dict ID
        - `submission_no` integer: Submission No
        - `submission_type` string: Submission Type
        - `drug_approval_id` string: Drug Approval Id
        - `original_regulation` string: Approval Category Original Value
        - `submission_classification` string: Registration Category
    - `fda` B019DrugApprovalDrugApprovalFdaDto
      - `products` B019DrugApprovalApprovalProductDto[]: Product Basic Info
        - `appl_no` string: FDA Application ID
        - `generic` integer: Generic, 0: No, 1: Yes
        - `strength` string: Strength
        - `appl_type` string: Application Type
        - `pack_size` string: Package Size
        - `biosimilar` integer: Biosimilar, 0: No, 1: Yes
        - `product_no` string: EMA Production Number
        - `trade_name` B019DrugApprovalCommonName[]: Trade Name
          - `lang` string: Language
          - `name` string: Drug,Target,Organization,Disease,Country/Location,DICT,Mechanism Action Name
        - `data_source` string: Data Source
        - `approval_date` integer: Approval Date
        - `market_status` B019DrugApprovalCommonDictionary
          - `display_name` B019DrugApprovalCommonName[]: Dict Name
            - `lang` string: Language
            - `name` string: Drug,Target,Organization,Disease,Country/Location,DICT,Mechanism Action Name
          - `normalized_id` string: Dict ID
        - `special_review` B019DrugApprovalCommonDictionary[]: Special Review
          - `display_name` B019DrugApprovalCommonName[]: Dict Name
            - `lang` string: Language
            - `name` string: Drug,Target,Organization,Disease,Country/Location,DICT,Mechanism Action Name
          - `normalized_id` string: Dict ID
        - `applicant_holder` B019DrugApprovalCommonOrganization[]: Organization
          - `display_name` B019DrugApprovalCommonName[]: Organization Name, Referencing "CommonName"
            - `lang` string: Language
            - `name` string: Drug,Target,Organization,Disease,Country/Location,DICT,Mechanism Action Name
          - `organization_id` string: Organization ID
        - `drug_approval_id` string: Drug Approval Id
        - `last_update_date` integer: Last Update
        - `first_approval_date` integer: First Approval Date
        - `product_data_source` B019DrugApprovalCommonName[]: Product Data Source
          - `lang` string: Language
          - `name` string: Drug,Target,Organization,Disease,Country/Location,DICT,Mechanism Action Name
        - `product_presentation` string: Package Type
        - `content_concentration` string: Volume
        - `dosage_form_and_route` B019DrugApprovalDosageFormAndRouteDto
          - `route` B019DrugApprovalCommonDictionary[]: Route
            - `display_name` B019DrugApprovalCommonName[]: Dict Name
              - …
            - `normalized_id` string: Dict ID
          - `dosage_from` B019DrugApprovalCommonDictionary[]: Dosage Form
            - `display_name` B019DrugApprovalCommonName[]: Dict Name
              - …
            - `normalized_id` string: Dict ID
          - `original_name` string: Original Name
      - `submissions` B019DrugApprovalApprovalSubmissionDto[]: Submission Basic Info
        - `disease` B019DrugApprovalCommonDisease[]: Indication
          - `disease_id` string: Disease ID
          - `display_name` B019DrugApprovalCommonName[]: Disease Name, Referencing "CommonName"
            - `lang` string: Language
            - `name` string: Drug,Target,Organization,Disease,Country/Location,DICT,Mechanism Action Name
        - `regulation` B019DrugApprovalCommonDictionary[]: Approval Category
          - `display_name` B019DrugApprovalCommonName[]: Dict Name
            - `lang` string: Language
            - `name` string: Drug,Target,Organization,Disease,Country/Location,DICT,Mechanism Action Name
          - `normalized_id` string: Dict ID
        - `action_date` integer: EMA Approval Date
        - `action_type` string: Result
        - `approval_date` integer: FDA Approval Date
        - `market_status` B019DrugApprovalCommonDictionary
          - `display_name` B019DrugApprovalCommonName[]: Dict Name
            - `lang` string: Language
            - `name` string: Drug,Target,Organization,Disease,Country/Location,DICT,Mechanism Action Name
          - `normalized_id` string: Dict ID
        - `submission_no` integer: Submission No
        - `submission_type` string: Submission Type
        - `drug_approval_id` string: Drug Approval Id
        - `original_regulation` string: Approval Category Original Value
        - `submission_classification` string: Registration Category
    - `nmpa` B019DrugApprovalDrugApprovalNmpaDto
      - `products` B019DrugApprovalApprovalProductDto[]: Product Basic Info
        - `appl_no` string: FDA Application ID
        - `generic` integer: Generic, 0: No, 1: Yes
        - `strength` string: Strength
        - `appl_type` string: Application Type
        - `pack_size` string: Package Size
        - `biosimilar` integer: Biosimilar, 0: No, 1: Yes
        - `product_no` string: EMA Production Number
        - `trade_name` B019DrugApprovalCommonName[]: Trade Name
          - `lang` string: Language
          - `name` string: Drug,Target,Organization,Disease,Country/Location,DICT,Mechanism Action Name
        - `data_source` string: Data Source
        - `approval_date` integer: Approval Date
        - `market_status` B019DrugApprovalCommonDictionary
          - `display_name` B019DrugApprovalCommonName[]: Dict Name
            - `lang` string: Language
            - `name` string: Drug,Target,Organization,Disease,Country/Location,DICT,Mechanism Action Name
          - `normalized_id` string: Dict ID
        - `special_review` B019DrugApprovalCommonDictionary[]: Special Review
          - `display_name` B019DrugApprovalCommonName[]: Dict Name
            - `lang` string: Language
            - `name` string: Drug,Target,Organization,Disease,Country/Location,DICT,Mechanism Action Name
          - `normalized_id` string: Dict ID
        - `applicant_holder` B019DrugApprovalCommonOrganization[]: Organization
          - `display_name` B019DrugApprovalCommonName[]: Organization Name, Referencing "CommonName"
            - `lang` string: Language
            - `name` string: Drug,Target,Organization,Disease,Country/Location,DICT,Mechanism Action Name
          - `organization_id` string: Organization ID
        - `drug_approval_id` string: Drug Approval Id
        - `last_update_date` integer: Last Update
        - `first_approval_date` integer: First Approval Date
        - `product_data_source` B019DrugApprovalCommonName[]: Product Data Source
          - `lang` string: Language
          - `name` string: Drug,Target,Organization,Disease,Country/Location,DICT,Mechanism Action Name
        - `product_presentation` string: Package Type
        - `content_concentration` string: Volume
        - `dosage_form_and_route` B019DrugApprovalDosageFormAndRouteDto
          - `route` B019DrugApprovalCommonDictionary[]: Route
            - `display_name` B019DrugApprovalCommonName[]: Dict Name
              - …
            - `normalized_id` string: Dict ID
          - `dosage_from` B019DrugApprovalCommonDictionary[]: Dosage Form
            - `display_name` B019DrugApprovalCommonName[]: Dict Name
              - …
            - `normalized_id` string: Dict ID
          - `original_name` string: Original Name
    - `pmda` B019DrugApprovalDrugApprovalPmdaDto
      - `products` B019DrugApprovalApprovalProductDto[]: Product Basic Info
        - `appl_no` string: FDA Application ID
        - `generic` integer: Generic, 0: No, 1: Yes
        - `strength` string: Strength
        - `appl_type` string: Application Type
        - `pack_size` string: Package Size
        - `biosimilar` integer: Biosimilar, 0: No, 1: Yes
        - `product_no` string: EMA Production Number
        - `trade_name` B019DrugApprovalCommonName[]: Trade Name
          - `lang` string: Language
          - `name` string: Drug,Target,Organization,Disease,Country/Location,DICT,Mechanism Action Name
        - `data_source` string: Data Source
        - `approval_date` integer: Approval Date
        - `market_status` B019DrugApprovalCommonDictionary
          - `display_name` B019DrugApprovalCommonName[]: Dict Name
            - `lang` string: Language
            - `name` string: Drug,Target,Organization,Disease,Country/Location,DICT,Mechanism Action Name
          - `normalized_id` string: Dict ID
        - `special_review` B019DrugApprovalCommonDictionary[]: Special Review
          - `display_name` B019DrugApprovalCommonName[]: Dict Name
            - `lang` string: Language
            - `name` string: Drug,Target,Organization,Disease,Country/Location,DICT,Mechanism Action Name
          - `normalized_id` string: Dict ID
        - `applicant_holder` B019DrugApprovalCommonOrganization[]: Organization
          - `display_name` B019DrugApprovalCommonName[]: Organization Name, Referencing "CommonName"
            - `lang` string: Language
            - `name` string: Drug,Target,Organization,Disease,Country/Location,DICT,Mechanism Action Name
          - `organization_id` string: Organization ID
        - `drug_approval_id` string: Drug Approval Id
        - `last_update_date` integer: Last Update
        - `first_approval_date` integer: First Approval Date
        - `product_data_source` B019DrugApprovalCommonName[]: Product Data Source
          - `lang` string: Language
          - `name` string: Drug,Target,Organization,Disease,Country/Location,DICT,Mechanism Action Name
        - `product_presentation` string: Package Type
        - `content_concentration` string: Volume
        - `dosage_form_and_route` B019DrugApprovalDosageFormAndRouteDto
          - `route` B019DrugApprovalCommonDictionary[]: Route
            - `display_name` B019DrugApprovalCommonName[]: Dict Name
              - …
            - `normalized_id` string: Dict ID
          - `dosage_from` B019DrugApprovalCommonDictionary[]: Dosage Form
            - `display_name` B019DrugApprovalCommonName[]: Dict Name
              - …
            - `normalized_id` string: Dict ID
          - `original_name` string: Original Name
  - `status` boolean, required: Status
  - `error_msg` string: Error Message
  - `error_code` integer, required: Error Code

## Other responses

- `401`: Unauthorized.
- `403`: Forbidden.
- `404`: Not Found.

---

[API](https://skmtc.dev/patsnap/apis/patsnap-open-platform-api.md) - [All operations](https://skmtc.dev/patsnap/apis/patsnap-open-platform-api/llms.txt) - [OpenAPI document](https://skmtc.dev/patsnap/apis/patsnap-open-platform-api/revisions/c2264a0de595?raw)