> ## Documentation Index
> Fetch the complete documentation index at: https://docs.pav.bio/llms.txt
> Use this file to discover all available pages before exploring further.

# List complete response letters

> Published complete response letters, one per letter. `status` is `Approved` if the application was later approved, else `Unapproved`. `from`/`to` filter on the letter date.



## OpenAPI

````yaml /openapi.json get /v1/fda/complete-response-letters
openapi: 3.1.0
info:
  title: Pav Enterprise API
  description: >-
    Read-only API over Pav's biopharma data: programs, drugs, companies, trials,
    deals, patents, FDA records and changes. Send `Authorization: Bearer
    <api_key>`. Lists return `{data, next_cursor, total}`; errors return
    `{error: {code, message, request_id}}`. Parameter rules:
    [Conventions](https://docs.pav.bio/conventions).
  version: 2.0.0
servers:
  - url: https://api.pav.bio
    description: Production
security: []
tags:
  - name: search
    description: Find the id of a company, drug, program, target or indication.
    x-group: Search
  - name: programs
    description: 'Drug programs: one drug in one indication at one company.'
    x-group: Programs
  - name: drugs
    description: >-
      One drug product across every company that develops it, under all its
      names, with its programs.
    x-group: Drugs
  - name: companies
    description: Biopharma companies, their owners and their trials.
    x-group: Companies
  - name: trials
    description: ClinicalTrials.gov trials linked to programs and companies.
    x-group: Trials
  - name: deals
    description: M&A, licensing and collaboration deals with terms and sources.
    x-group: Deals
  - name: patents
    description: US patent families with owners, members and term.
    x-group: Patents
  - name: fda
    description: FDA records, one endpoint per record type.
    x-group: FDA
  - name: changes
    description: Program and trial changes, newest first.
    x-group: Changes
  - name: stats
    description: Dataset counts.
    x-group: Stats
paths:
  /v1/fda/complete-response-letters:
    get:
      tags:
        - fda
      summary: List complete response letters
      description: >-
        Published complete response letters, one per letter. `status` is
        `Approved` if the application was later approved, else `Unapproved`.
        `from`/`to` filter on the letter date.
      operationId: list_fda_complete_response_letters
      parameters:
        - name: q
          in: query
          required: false
          schema:
            anyOf:
              - type: string
                maxLength: 200
              - type: 'null'
            description: Part of the title, description, company or FDA id.
            title: Q
          description: Part of the title, description, company or FDA id.
        - name: company_id
          in: query
          required: false
          schema:
            anyOf:
              - items:
                  type: string
                type: array
              - type: 'null'
            description: >-
              Company ids, comma-separated. Includes the companies each one
              owns.
            examples:
              - '412'
            title: Company Id
          description: Company ids, comma-separated. Includes the companies each one owns.
        - name: application_key
          in: query
          required: false
          schema:
            anyOf:
              - type: string
                maxLength: 32
              - type: 'null'
            description: FDA application, e.g. `N:209637` or `BLA:761508`.
            title: Application Key
          description: FDA application, e.g. `N:209637` or `BLA:761508`.
        - name: status
          in: query
          required: false
          schema:
            anyOf:
              - items:
                  type: string
                type: array
              - type: 'null'
            description: Statuses, comma-separated (case-insensitive).
            title: Status
          description: Statuses, comma-separated (case-insensitive).
        - name: from
          in: query
          required: false
          schema:
            anyOf:
              - type: string
                format: date
              - type: 'null'
            description: On or after this date.
            title: From
          description: On or after this date.
        - name: to
          in: query
          required: false
          schema:
            anyOf:
              - type: string
                format: date
              - type: 'null'
            description: On or before this date.
            title: To
          description: On or before this date.
        - name: sort
          in: query
          required: false
          schema:
            anyOf:
              - type: string
              - type: 'null'
            description: '`document_date` or `event_date`; prefix `-` to descend.'
            title: Sort
          description: '`document_date` or `event_date`; prefix `-` to descend.'
        - name: limit
          in: query
          required: false
          schema:
            type: integer
            maximum: 200
            minimum: 1
            description: Rows per page (1-200).
            examples:
              - 50
            default: 50
            title: Limit
          description: Rows per page (1-200).
        - name: cursor
          in: query
          required: false
          schema:
            anyOf:
              - type: string
                maxLength: 2000
              - type: 'null'
            description: '`next_cursor` from the previous page.'
            title: Cursor
          description: '`next_cursor` from the previous page.'
      responses:
        '200':
          description: Successful Response
          content:
            application/json:
              schema:
                $ref: '#/components/schemas/FdaListResponse'
        '400':
          description: Invalid parameter (`validation_error`).
          content:
            application/json:
              schema:
                $ref: '#/components/schemas/ErrorEnvelope'
        '401':
          description: Missing or invalid API key (`unauthorized`).
          content:
            application/json:
              schema:
                $ref: '#/components/schemas/ErrorEnvelope'
        '404':
          description: Unknown id or route (`not_found`).
          content:
            application/json:
              schema:
                $ref: '#/components/schemas/ErrorEnvelope'
        '429':
          description: Rate limit exceeded (`rate_limited`); honor `Retry-After`.
          content:
            application/json:
              schema:
                $ref: '#/components/schemas/ErrorEnvelope'
      security:
        - EnterpriseApiKey: []
components:
  schemas:
    FdaListResponse:
      properties:
        data:
          items:
            $ref: '#/components/schemas/FdaRecord'
          type: array
          title: Data
          description: Page of FDA records.
        next_cursor:
          anyOf:
            - type: string
            - type: 'null'
          title: Next Cursor
          description: >-
            Pass as `cursor` to get the next page. Null on the last page. See
            [Conventions](https://docs.pav.bio/conventions).
          examples:
            - eyJyIjoicHJvZ3JhbXMiLCJzIjoiY29tcGFueSJ9
        total:
          anyOf:
            - type: integer
            - type: 'null'
          title: Total
          description: Rows matching the filters. Null for relevance-ranked `q` results.
          examples:
            - 1284
      type: object
      required:
        - data
      title: FdaListResponse
    ErrorEnvelope:
      properties:
        error:
          $ref: '#/components/schemas/ErrorBody'
          description: Error detail. Present only on 4xx/5xx responses.
      required:
        - error
      title: ErrorEnvelope
      type: object
    FdaRecord:
      properties:
        record_key:
          type: string
          title: Record Key
          description: >-
            Durable key built from FDA identifiers; use it with `GET
            /v1/fda/{record_key}`.
          examples:
            - purple_book_product:761508:001
        record_type:
          type: string
          enum:
            - orange_book_product
            - orange_book_patent
            - orange_book_exclusivity
            - purple_book_product
            - orphan_designation
            - warning_letter
            - recall
            - drug_application
            - complete_response_letter
            - accelerated_approval
            - advisory_committee_meeting
          title: Record Type
          description: Kind of FDA record.
          examples:
            - purple_book_product
        source:
          type: string
          title: Source
          description: FDA publication the record comes from.
          examples:
            - purple_book
        source_version:
          anyOf:
            - type: string
            - type: 'null'
          title: Source Version
          description: >-
            Source edition: `YYYY-MM` for Orange and Purple Book, the load date
            for orphan designations, null for continuously published sources.
          examples:
            - 2026-08
        fda_organization_name:
          anyOf:
            - type: string
            - type: 'null'
          title: Fda Organization Name
          description: Applicant, sponsor or recipient name as FDA spells it.
          examples:
            - Regeneron Pharmaceuticals, Inc.
        company:
          anyOf:
            - $ref: '#/components/schemas/FdaCompany'
            - type: 'null'
          description: The linked company; null when the FDA name is not linked.
        application_key:
          anyOf:
            - type: string
            - type: 'null'
          title: Application Key
          description: 'FDA application: `N:` (NDA), `A:` (ANDA) or `BLA:` plus the number.'
          examples:
            - BLA:761508
        product_key:
          anyOf:
            - type: string
            - type: 'null'
          title: Product Key
          description: Application plus the FDA product number.
          examples:
            - BLA:761508:001
        designation_id:
          anyOf:
            - type: string
            - type: 'null'
          title: Designation Id
          description: FDA orphan designation id; there is one record per designation.
          examples:
            - '1186826'
        patent_number:
          anyOf:
            - type: string
            - type: 'null'
          title: Patent Number
          description: Orange Book listed US patent number.
          examples:
            - '10022461'
        title:
          type: string
          title: Title
          description: >-
            Display title: trade name, patent label, letter subject or recalled
            product.
          examples:
            - GENGLYCOS
        description:
          anyOf:
            - type: string
            - type: 'null'
          title: Description
          description: >-
            Ingredient for products, patents and exclusivities; indication for
            orphan designations; subject or reason for letters and recalls.
        document_date:
          anyOf:
            - type: string
              format: date
            - type: 'null'
          title: Document Date
          description: Date FDA issued the record (approval, letter, recall, designation).
        event_date:
          anyOf:
            - type: string
              format: date
            - type: 'null'
          title: Event Date
          description: The date `event_date_type` names, e.g. a patent expiry.
        event_date_type:
          anyOf:
            - type: string
            - type: 'null'
          title: Event Date Type
          description: >-
            What `event_date` is: `approval`, `patent_expiry`,
            `exclusivity_expiry`, `orphan_exclusivity_expiry`, or another event.
          examples:
            - patent_expiry
        status:
          anyOf:
            - type: string
            - type: 'null'
          title: Status
          description: >-
            Source status: marketing status for products (`RX`, `OTC`, `DISCN`),
            `listed` or `delisted` for patents, the code for exclusivities, the
            latest action otherwise.
          examples:
            - RX
        source_url:
          anyOf:
            - type: string
            - type: 'null'
          title: Source Url
          description: >-
            Official FDA page for the record. Orange Book patents and
            exclusivities link to their product's patent and exclusivity page.
        details:
          $ref: '#/components/schemas/FdaRecordDetails'
          description: Record-type specific source fields.
      type: object
      required:
        - record_key
        - record_type
        - source
        - title
      title: FdaRecord
    ErrorBody:
      properties:
        code:
          description: >-
            Stable, machine-readable error code (e.g. `unauthorized`,
            `not_found`, `validation_error`, `error`).
          examples:
            - not_found
          title: Code
          type: string
        message:
          description: Human-readable explanation of the error.
          examples:
            - program 999999 not found
          title: Message
          type: string
        request_id:
          anyOf:
            - type: string
            - type: 'null'
          default: null
          description: >-
            Correlation id echoed in the `X-Request-ID` response header. Quote
            it when contacting Pav support about a failed request.
          examples:
            - 3f2b9c1d8a7e4f6b9c0d1e2f3a4b5c6d
          title: Request Id
      required:
        - code
        - message
      title: ErrorBody
      type: object
    FdaCompany:
      properties:
        company_id:
          type: integer
          title: Company Id
          description: Durable Pav company identifier.
          examples:
            - 5093
        short_name:
          type: string
          title: Short Name
          description: Company slug.
          examples:
            - regeneron
        name:
          type: string
          title: Name
          description: Company display name.
          examples:
            - Regeneron Pharmaceuticals
      type: object
      required:
        - company_id
        - short_name
        - name
      title: FdaCompany
    FdaRecordDetails:
      properties:
        ingredient:
          anyOf:
            - type: string
            - type: 'null'
          title: Ingredient
          description: Orange Book active ingredient(s) as FDA lists them.
          examples:
            - SEMAGLUTIDE
        strength:
          anyOf:
            - type: string
            - type: 'null'
          title: Strength
          description: Orange Book / Purple Book strength.
          examples:
            - 300MG/5ML (60MG/ML)
        dosage_route:
          anyOf:
            - type: string
            - type: 'null'
          title: Dosage Route
          description: Orange Book dosage form and route, `FORM;ROUTE`.
          examples:
            - TABLET;ORAL
        dosage_form:
          anyOf:
            - type: string
            - type: 'null'
          title: Dosage Form
          description: Purple Book dosage form.
          examples:
            - Injection
        route:
          anyOf:
            - type: string
            - type: 'null'
          title: Route
          description: Purple Book route of administration.
          examples:
            - Intravenous
        therapeutic_equivalence_code:
          anyOf:
            - type: string
            - type: 'null'
          title: Therapeutic Equivalence Code
          description: >-
            Orange Book therapeutic-equivalence (TE) code; set only for
            multisource products.
          examples:
            - AB1
        reference_listed_drug:
          anyOf:
            - type: boolean
            - type: 'null'
          title: Reference Listed Drug
          description: 'Orange Book: the product is a reference listed drug (RLD).'
        reference_standard:
          anyOf:
            - type: boolean
            - type: 'null'
          title: Reference Standard
          description: 'Orange Book: the product is the reference standard (RS).'
        patent_use_code:
          anyOf:
            - type: string
            - type: 'null'
          title: Patent Use Code
          description: Orange Book patent use code (method-of-use claim), when listed.
          examples:
            - U-4597
        pediatric_extension:
          anyOf:
            - type: boolean
            - type: 'null'
          title: Pediatric Extension
          description: 'Orange Book patent: the expiry includes pediatric exclusivity.'
        drug_substance_claim:
          anyOf:
            - type: boolean
            - type: 'null'
          title: Drug Substance Claim
          description: Orange Book patent claims the drug substance. Null when not flagged.
        drug_product_claim:
          anyOf:
            - type: boolean
            - type: 'null'
          title: Drug Product Claim
          description: Orange Book patent claims the drug product. Null when not flagged.
        license_type:
          anyOf:
            - type: string
            - type: 'null'
          title: License Type
          description: >-
            Purple Book pathway: `351(a)` (reference product) or `351(k)`
            (biosimilar).
          examples:
            - 351(a)
        licensure:
          anyOf:
            - type: string
            - type: 'null'
          title: Licensure
          description: Purple Book licensure status.
          examples:
            - Licensed
        license_number:
          anyOf:
            - type: string
            - type: 'null'
          title: License Number
          description: Purple Book US license number of the holder.
          examples:
            - '1760'
        orphan_exclusivity_expiry:
          anyOf:
            - type: string
              format: date
            - type: 'null'
          title: Orphan Exclusivity Expiry
          description: Purple Book orphan exclusivity expiry.
        reference_product_exclusivity_expiry:
          anyOf:
            - type: string
              format: date
            - type: 'null'
          title: Reference Product Exclusivity Expiry
          description: Purple Book 12-year reference product exclusivity expiry.
        approval_date_raw:
          anyOf:
            - type: string
            - type: 'null'
          title: Approval Date Raw
          description: >-
            FDA's approval date text when it is not a date (products before
            1982).
          examples:
            - Approved Prior to Jan 1, 1982
        generic_name:
          anyOf:
            - type: string
            - type: 'null'
          title: Generic Name
          description: 'Orphan designation: generic name as the sponsor filed it.'
          examples:
            - inosine pranobex
        designation_withdrawn_date:
          anyOf:
            - type: string
              format: date
            - type: 'null'
          title: Designation Withdrawn Date
          description: 'Orphan designation: date the designation was withdrawn.'
        approvals:
          anyOf:
            - items:
                $ref: '#/components/schemas/FdaOrphanApproval'
              type: array
            - type: 'null'
          title: Approvals
          description: >-
            Orphan designation: every marketing approval under this designation,
            oldest first. Empty when the designated product is not approved for
            it.
        brand:
          anyOf:
            - type: string
            - type: 'null'
          title: Brand
          description: 'Recall: brand name(s) as FDA lists them.'
          examples:
            - Baxter
        reason:
          anyOf:
            - type: string
            - type: 'null'
          title: Reason
          description: Recall reason category.
          examples:
            - Mislabeling
        reason_description:
          anyOf:
            - type: string
            - type: 'null'
          title: Reason Description
          description: Recall reason as FDA describes it.
        product_types:
          anyOf:
            - items:
                type: string
              type: array
            - type: 'null'
          title: Product Types
          description: >-
            Recall product types. Only recalls that include drugs, biologics or
            medical devices are in this feed.
          examples:
            - - Drugs
        issuing_office:
          anyOf:
            - type: string
            - type: 'null'
          title: Issuing Office
          description: >-
            Warning letter issuing office. The feed holds letters from FDA's
            drug, biologic and medical device offices.
          examples:
            - Center for Drug Evaluation and Research (CDER)
        fda_reference_id:
          anyOf:
            - type: string
            - type: 'null'
          title: Fda Reference Id
          description: Warning letter FDA reference number.
          examples:
            - '738238'
        closeout_date:
          anyOf:
            - type: string
              format: date
            - type: 'null'
          title: Closeout Date
          description: Warning letter close-out date, once FDA closed it out.
        application_type:
          anyOf:
            - type: string
            - type: 'null'
          title: Application Type
          description: 'Drug application: `NDA`, `ANDA` (generic) or `BLA`.'
          examples:
            - NDA
        products:
          anyOf:
            - type: string
            - type: 'null'
          title: Products
          description: >-
            Drug application and complete response letter: the application's
            product names.
          examples:
            - NUBEQA
        submission_count:
          anyOf:
            - type: integer
            - type: 'null'
          title: Submission Count
          description: 'Drug application: number of submissions FDA lists.'
        latest_submission:
          anyOf:
            - $ref: '#/components/schemas/FdaSubmission'
            - type: 'null'
          description: 'Drug application: the most recent FDA action on a submission.'
        letter_type:
          anyOf:
            - type: string
            - type: 'null'
          title: Letter Type
          description: 'Complete response letter: the letter type as FDA files it.'
          examples:
            - COMPLETE RESPONSE
        application_numbers:
          anyOf:
            - items:
                type: string
              type: array
            - type: 'null'
          title: Application Numbers
          description: 'Complete response letter: every application the letter answers.'
          examples:
            - - NDA 218705
        category:
          anyOf:
            - type: string
            - type: 'null'
          title: Category
          description: 'Accelerated approval: FDA''s list, `cancer`, `infectious` or `other`.'
          examples:
            - cancer
        current_status:
          anyOf:
            - type: string
            - type: 'null'
          title: Current Status
          description: 'Accelerated approval: FDA''s status note, e.g. the conversion date.'
          examples:
            - Traditional Approval Granted (12/16/2022)
        confirmatory_requirements:
          anyOf:
            - items:
                $ref: '#/components/schemas/FdaConfirmatoryRequirement'
              type: array
            - type: 'null'
          title: Confirmatory Requirements
          description: 'Accelerated approval: the confirmatory trial requirements FDA lists.'
        center:
          anyOf:
            - type: string
            - type: 'null'
          title: Center
          description: 'Advisory committee meeting: the FDA center that convened it.'
          examples:
            - Center for Drug Evaluation and Research
        meeting_start:
          anyOf:
            - type: string
              format: date-time
            - type: 'null'
          title: Meeting Start
          description: 'Advisory committee meeting: start time (UTC).'
        meeting_end:
          anyOf:
            - type: string
              format: date-time
            - type: 'null'
          title: Meeting End
          description: 'Advisory committee meeting: end time (UTC).'
        documents:
          anyOf:
            - items:
                $ref: '#/components/schemas/FdaMeetingDocument'
              type: array
            - type: 'null'
          title: Documents
          description: >-
            Advisory committee meeting: briefing documents, minutes and other
            materials.
      type: object
      title: FdaRecordDetails
      description: >-
        Source fields for one record. Each field applies to the record types
        named in it.
    FdaOrphanApproval:
      properties:
        marketing_approval_date:
          anyOf:
            - type: string
              format: date
            - type: 'null'
          title: Marketing Approval Date
          description: Approval date.
        exclusivity_end_date:
          anyOf:
            - type: string
              format: date
            - type: 'null'
          title: Exclusivity End Date
          description: Orphan exclusivity end date for this approval.
        trade_name:
          anyOf:
            - type: string
            - type: 'null'
          title: Trade Name
          description: Trade name of the approved product.
          examples:
            - Darzalex
        generic_name:
          anyOf:
            - type: string
            - type: 'null'
          title: Generic Name
          description: Generic name of the approved product.
          examples:
            - daratumumab
        approved_labeled_indication:
          anyOf:
            - type: string
            - type: 'null'
          title: Approved Labeled Indication
          description: The approved labeled indication.
        protected_indication:
          anyOf:
            - type: string
            - type: 'null'
          title: Protected Indication
          description: The indication the orphan exclusivity protects.
      type: object
      title: FdaOrphanApproval
      description: One marketing approval under an orphan designation.
    FdaSubmission:
      properties:
        submission_type:
          anyOf:
            - type: string
            - type: 'null'
          title: Submission Type
          description: '`ORIG` (original) or `SUPPL` (supplement).'
          examples:
            - SUPPL
        submission_number:
          anyOf:
            - type: string
            - type: 'null'
          title: Submission Number
          examples:
            - '16'
        status:
          anyOf:
            - type: string
            - type: 'null'
          title: Status
          description: FDA action code, e.g. `AP` (approved) or `TA` (tentative approval).
          examples:
            - AP
        status_date:
          anyOf:
            - type: string
              format: date
            - type: 'null'
          title: Status Date
          description: Date of the action.
        submission_class:
          anyOf:
            - type: string
            - type: 'null'
          title: Submission Class
          description: What the submission changed.
          examples:
            - Labeling
        review_priority:
          anyOf:
            - type: string
            - type: 'null'
          title: Review Priority
          description: '`STANDARD` or `PRIORITY` review.'
          examples:
            - PRIORITY
        notes:
          anyOf:
            - type: string
            - type: 'null'
          title: Notes
          description: FDA's public note, when given.
      type: object
      title: FdaSubmission
      description: One FDA action on a drug application submission.
    FdaConfirmatoryRequirement:
      properties:
        requirement:
          anyOf:
            - type: string
            - type: 'null'
          title: Requirement
          description: The confirmatory study requirement as FDA words it.
        projected_completion:
          anyOf:
            - type: string
              format: date
            - type: 'null'
          title: Projected Completion
          description: FDA's projected completion date for it.
      type: object
      title: FdaConfirmatoryRequirement
    FdaMeetingDocument:
      properties:
        title:
          anyOf:
            - type: string
            - type: 'null'
          title: Title
          description: Document title.
        url:
          anyOf:
            - type: string
            - type: 'null'
          title: Url
          description: Official FDA link.
        document_type:
          anyOf:
            - type: string
            - type: 'null'
          title: Document Type
          description: Kind of document.
        document_date:
          anyOf:
            - type: string
              format: date
            - type: 'null'
          title: Document Date
          description: Document date, when given.
      type: object
      title: FdaMeetingDocument
  securitySchemes:
    EnterpriseApiKey:
      type: http
      description: >-
        Use a personal or organization Pav API key from Pav developer settings.
        Send it as Authorization: Bearer <api_key>.
      scheme: bearer
      bearerFormat: Pav API key

````