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Working With The FDA2253 API

FDA2253 Endpoint Overview​

The FDA2253 endpoint allows you to generate a populated FDA2253 PDF form. The form is returned as a file and is not stored in Aprimo. You can use additional Aprimo endpoints to upload and store the document in the appropriate location (e.g., as an attachment or digital asset).

Key Features​

  • Supports all form fields (except the signature field), including multiple rows in section 8.
  • Allows generating a blank form by passing an empty body.
  • Optionally, include the query string parameter ?flatten=true to retrieve a flattened PDF.

Usage Notes​

  • This endpoint does not read or write data to/from Aprimo. Use other endpoints to fetch Aprimo data needed for the form.
  • The generated PDF is not stored in Aprimo, allowing flexibility to store it in a location of your choice.

JSON Schema​

Below is the schema for the FDA2253 endpoint:

{
  "$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" }
          }
        }
      ]
    },
    "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" }
  }
}

Example Features​

  • Generate a Populated Form: Provide as much or as little data as required to populate the form.
  • Blank Form: Submit an empty request body to retrieve a blank form.
  • Flattened PDF: Add ?flatten=true to the URL to generate a non-editable version of the form.

The schema supports dynamic configurations, offering flexibility for various use cases.

Field Definitions​

The sections below outline the numbered sections in the FDA2253 form and their corresponding JSON properties.

Section 1​

  • DateSubmitted: MM/DD/YYYY format.

Section 2​

  • LabelReviewNumber

Section 3: NDA/ANDA/AADA or BLA/PMA​

  • Type: String of dropdown value (e.g., "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: ProfessionalOrConsumer (true for Professional, false for Consumer).
  • AdvertisementMaterials: Collection containing:
    • MaterialType: String of dropdown value (e.g., "Audio").
    • PublicationDate: Dissemination/Publication Date.
    • MaterialIdCode: Material ID Code.
    • MaterialDescription: Material Description.
  • 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​

  • Signature: Not supported (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	
}