Working with the FDA2253 API

Introduction

The FDA2253 Endpoint allows you to pass in a set of data to populate an FDA2253 PDF form. The endpoint will return the contents of the form as a file to you. The endpoint does not read or write any data to or from Aprimo – you must use other endpoints to pull the appropriate Aprimo data to populate on the form. Additionally, the endpoint does not store the document anywhere in Aprimo. Many of our customers have different needs as to where and how to store this document (for example, as an attachment on an activity or as an asset in the Aprimo DAM), so once the document is returned, you may use additional endpoints to upload it into Aprimo at the proper location for you.

When generating a form, you may pass in as little or as much data as you’d like. All form fields aside from the Signature field are supported to be filled out, including multiple rows in section 8. You may even pass in a blank body in the request to get a blank copy of the form returned.

Optionally, you may also pass in a flatten=true query string parameter in the URL (i.e. /api/fda2253?flatten=true) to retrieve a flattened version of the PDF form.

Schema

The JSON Schema for the endpoint is as follows:

{
  "$schema": "http://json-schema.org/draft-04/schema#",
  "type": "object",
  "properties": {
    "DateSubmitted": {
      "type": "string"
    },
    "LabelReviewNumber": {
      "type": "string"
    },
    "Type": {
      "type": "string"
    },
    "Number": {
      "type": "string"
    },
    "SingleProductOrMultiple": {
      "type": "boolean"
    },
    "ProprietaryName": {
      "type": "string"
    },
    "EstablishedName": {
      "type": "string"
    },
    "ProductCodeNo": {
      "type": "string"
    },
    "PackageInsertDateAndIdNumber": {
      "type": "string"
    },
    "ManufacturerName": {
      "type": "string"
    },
    "LicenseNoBiologics": {
      "type": "integer"
    },
    "ProfessionalOrConsumer": {
      "type": "boolean"
    },
    "AdvertisementMaterials": {
      "type": "array",
      "items": [
        {
          "type": "object",
          "properties": {
            "MaterialType": {
              "type": "string"
            },
            "PublicationDate": {
              "type": "string"
            },
            "MaterialIdCode": {
              "type": "string"
            },
            "MaterialDescription": {
              "type": "string"
            }
          }
        },
        {
          "type": "object",
          "properties": {
            "MaterialType": {
              "type": "null"
            },
            "PublicationDate": {
              "type": "null"
            },
            "MaterialIdCode": {
              "type": "null"
            },
            "MaterialDescription": {
              "type": "null"
            }
          }
        }
      ]
    },
    "Comments": {
      "type": "string"
    },
    "Address1": {
      "type": "string"
    },
    "Address2": {
      "type": "string"
    },
    "City": {
      "type": "string"
    },
    "State": {
      "type": "string"
    },
    "Country": {
      "type": "string"
    },
    "ZipCode": {
      "type": "string"
    },
    "Phone": {
      "type": "string"
    },
    "Fax": {
      "type": "string"
    },
    "Email": {
      "type": "string"
    },
    "TypedNameOfAgent": {
      "type": "string"
    },
    "DateSigned": {
      "type": "string"
    },
    "DraftOrFinalForCberProductsOnly": {
      "type": "boolean"
    }
  }
}

Field Definitions

The following section outlines the numbered sections in the FDA2253 form and the JSON properties that set their values.
Section 1:
DateSubmitted (MM/DD/YYYY)

 

Section 2:
LabelReviewNumber

 

Section 3: NDA/ANDA/AADA or BLA/PMA
Type (use a string of the dropdown value, i.e. “NDA”)
Number
SingleProductOrMultiple (true for Single, false for Multiple)

 

Section 4
ProprietaryName

 

Section 5
EstablishedName
ProductCodeNo

 

Section 6
PackageInsertDateAndIdNumber

 

Section 7
ManufacturerName
LicenseNoBiologics

 

Section 8: Advertising/Promotional Label Materials
8a Please check only one: ProfessionalOrConsumer (true for Professional, false for Consumer)
AdvertisementMaterials (collection)
         b Material type (use FDA codes): MaterialType (set value to string of dropdown option, i.e. “Audio”)
         c Dissemination/Publication Date.: PublicationDate
         d Material ID Code: MaterialIdCode
         e Material Description: MaterialDescription
 f Comments: Comments

 

Section 9: Applicant’s (or Agent’s) Return Address
Address1
Address2
City
State
Country
ZipCode

 

Section 10: Responsible Official’s (or Agent’s)
Phone
Fax
Email

 

Section 11
TypedNameOfAgent

 

Section 12
The Signature of Responsible Official or Agent field is not supported, as Aprimo cannot sign on behalf of a person.

 

Section 13
DateSigned

 

Section 14
DraftOrFinalForCberProductsOnly (true for Draft, false for Final)

Sample JSON

Please see a full sample JSON below.

{
	"DateSubmitted" : "01/01/2019",
	"LabelReviewNumber" : "12345",
	"Type" : "NDA",
	"Number" : "12345",
	"SingleProductOrMultiple" : true,
	"ProprietaryName" : "My Proprietary Name",
	"EstablishedName" : "My Established Name",
	"ProductCodeNo" : "P12345",
	"ProfessionalOrConsumer" : true,
	"PackageInsertDateAndIdNumber" : "01/01/2019 ID123",
	"ManufacturerName" : "Aprimo",
	"LicenseNoBiologics" : "L12308",
	"AdvertisementMaterials" : [
		{
		"MaterialType" : "Audio",
		"PublicationDate" : "01/01/2019",
		"MaterialIdCode" : "M101",
		"MaterialDescription" : "Audio for Promo"
		},
		{
		"MaterialType" : "Video",
		"PublicationDate" : "01/01/2019",
		"MaterialIdCode" : "M102",
		"MaterialDescription" : "Video for Promo"
		}
	],
	"Comments" : "My comments for this...",
	"Address1" : "230 W Monroe",
	"Address2" : "Suite 1200",
	"City" : "Chicago",
	"State" : "IL",
	"Country" : "USA",
	"ZipCode" : "60606",
	"Phone" : "555-555-5555",
	"Fax" : "555-555-5555",
	"Email" : "integrations@aprimo.com",
	"TypedNameOfAgent" : "Aprimo Integrations",
	"DateSigned": "01/01/2019",
	"DraftOrFinalForCberProductsOnly" : true	
}