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Dapagliflozin (Farxiga)

Farxiga is the brand name of dapagliflozin tablets, an SGLT2 inhibitor. The US FDA approved the application on 8 January 2014. The FDA records fetched here do not say what the medicine was approved to treat in 2014, and they do not say which later changes added other uses, including for heart failure. This page records the application and the trials of the medicine are on the dapagliflozin page.

Also called Farxiga · FARXIGA

  • Product
  • In this atlas

Overview

Technical summary

FDA application NDA202293. The openFDA record names ASTRAZENECA AB as the sponsor and lists AstraZeneca Pharmaceuticals LP among the manufacturer names in its openFDA block, and also lists a second manufacturer name (Prasco Laboratories). The Research Organization Registry lists AstraZeneca (Sweden) among the child organizations of AstraZeneca (United Kingdom); this page does not say whether ASTRAZENECA AB is that organization.

Product details

Type
Medicine
Model or formulation
Dapagliflozin tablets
Version
The openFDA record lists tablets of two strengths. Current labelling was not read.

Intended-use sources

No intended-use source is recorded.

Claims and evidence

Context United States approval record NDA202293 for Farxiga (dapagliflozin)

Recipient
Recipient not specified
Population
Not stated in the fetched FDA records. They name a product and a sponsor and give no intended population or indication for the original approval.
Care setting
Not stated in the FDA records
Geography
United States (decision by the US Food and Drug Administration)
Life stage
Not stated in the FDA records
Gestational age
Not reported
Postnatal age
Not reported
Follow-up
Not applicable (regulatory decision)
Eligibility: inclusion criteria not stated; exclusion criteria not stated
Included
None stated
Excluded
None stated

  • Regulatory Evidence stage not applicable Certainty not assessed

    The US Food and Drug Administration approved New Drug Application NDA202293 for FARXIGA (dapagliflozin) tablets on 8 January 2014. The openFDA record lists the original approval as submission ORIG-1, classified as Type 1 - New Molecular Entity, with standard review priority. The openFDA record names ASTRAZENECA AB as the sponsor of the application.

    Applies to Recipient not specified
    • Not stated in the fetched FDA records. They name a product and a sponsor and give no intended population or indication for the original approval.
    • Not stated in the FDA records
    • United States (decision by the US Food and Drug Administration)
    • Not stated in the FDA records
    • Gestational age Not reported
    • Postnatal age Not reported
    Follow-up Not applicable (regulatory decision)
    Certainty method
    Not assessed
    Limitations
    This claim records the original approval and the fields the records give. The records fetched carry no indication text for the original approval, so the claim does not say what the medicine was approved to treat then. The openFDA record also lists later submissions, mostly supplements, and the fetched records do not say which of them changed the approved uses, including for heart failure. Current labelling was not read. An approval is not a finding about how well the medicine works. openFDA's own disclaimer says not to rely on it for decisions about medical care.
    Last checked
    2026-10-14
    Next evidence check due
    Not scheduled
    Sources and citations (10)

    1. Supports openFDA Drugs@FDA record for NDA202293: FARXIGA (dapagliflozin tablets)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA drugsfda record returned on 2026-10-14, from a dataset last updated 2026-10-13. The record lists the application, its products and its submissions. It does not carry indication text. · NDA: NDA202293

      Locator
      results[0].application_number
      How it applies
      The application number of this record.
      Retrieved
      Source effective date
      2026-10-13
      Source state
      Current
      Snapshot hash
      8ab438a43402f351d1d4a925cbe1dd4855c4e5a8f29f85e62c6495e53168a53a
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as ce-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2, hash only). The raw record is committed at research/snapshots/ce-openfda-nda202293.json.

    2. Supports Drugs@FDA overview page for NDA 202293 (FARXIGA)

      Regulator · U.S. Food and Drug Administration (Drugs@FDA) · Edition Drugs@FDA application overview page fetched 2026-10-14. It lists the original approval date as a month-first slash date.

      Locator
      Original Approvals or Tentative Approvals table, Action Date (MM/DD/YYYY)
      How it applies
      Original approval date and submission ORIG-1. The page writes the date month first; it is used only for the date.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      c6c3912b45b7c3a4bbba413fc5ef010ff18266acee7d609225f7c63b6c73b256
      Reuse basis
      The FDA website policies page (fetched as ce-fda-website-policies.html, sha256 59b7c85417532ac45d5c62ed35646d399324edfc2cee023684995302e4eeb9b3, hash only) says the contents of www.fda.gov are not copyrighted. This page is served from www.accessdata.fda.gov, which that policy page does not name, so the reuse terms are treated as unverified. The raw page is committed at research/snapshots/ce-fda-daf-nda202293.html.

    3. Supports openFDA Drugs@FDA record for NDA202293: FARXIGA (dapagliflozin tablets)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA drugsfda record returned on 2026-10-14, from a dataset last updated 2026-10-13. The record lists the application, its products and its submissions. It does not carry indication text. · NDA: NDA202293

      Locator
      results[0].submissions[16].submission_class_code_description
      How it applies
      The submission classification of the original approval.
      Retrieved
      Source effective date
      2026-10-13
      Source state
      Current
      Snapshot hash
      8ab438a43402f351d1d4a925cbe1dd4855c4e5a8f29f85e62c6495e53168a53a
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as ce-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2, hash only). The raw record is committed at research/snapshots/ce-openfda-nda202293.json.

    4. Supports openFDA Drugs@FDA record for NDA202293: FARXIGA (dapagliflozin tablets)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA drugsfda record returned on 2026-10-14, from a dataset last updated 2026-10-13. The record lists the application, its products and its submissions. It does not carry indication text. · NDA: NDA202293

      Locator
      results[0].submissions[16].review_priority
      How it applies
      The review priority of the original approval.
      Retrieved
      Source effective date
      2026-10-13
      Source state
      Current
      Snapshot hash
      8ab438a43402f351d1d4a925cbe1dd4855c4e5a8f29f85e62c6495e53168a53a
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as ce-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2, hash only). The raw record is committed at research/snapshots/ce-openfda-nda202293.json.

    5. Supports openFDA Drugs@FDA record for NDA202293: FARXIGA (dapagliflozin tablets)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA drugsfda record returned on 2026-10-14, from a dataset last updated 2026-10-13. The record lists the application, its products and its submissions. It does not carry indication text. · NDA: NDA202293

      Locator
      results[0].submissions[16].submission_status_date
      How it applies
      The openFDA submission list gives the same original approval date in compact form.
      Retrieved
      Source effective date
      2026-10-13
      Source state
      Current
      Snapshot hash
      8ab438a43402f351d1d4a925cbe1dd4855c4e5a8f29f85e62c6495e53168a53a
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as ce-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2, hash only). The raw record is committed at research/snapshots/ce-openfda-nda202293.json.

    6. Supports openFDA Drugs@FDA record for NDA202293: FARXIGA (dapagliflozin tablets)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA drugsfda record returned on 2026-10-14, from a dataset last updated 2026-10-13. The record lists the application, its products and its submissions. It does not carry indication text. · NDA: NDA202293

      Locator
      results[0].sponsor_name
      How it applies
      The application sponsor, as the record writes the name.
      Retrieved
      Source effective date
      2026-10-13
      Source state
      Current
      Snapshot hash
      8ab438a43402f351d1d4a925cbe1dd4855c4e5a8f29f85e62c6495e53168a53a
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as ce-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2, hash only). The raw record is committed at research/snapshots/ce-openfda-nda202293.json.

    7. Supports openFDA Drugs@FDA record for NDA202293: FARXIGA (dapagliflozin tablets)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA drugsfda record returned on 2026-10-14, from a dataset last updated 2026-10-13. The record lists the application, its products and its submissions. It does not carry indication text. · NDA: NDA202293

      Locator
      results[0].products[0].brand_name
      How it applies
      The brand name.
      Retrieved
      Source effective date
      2026-10-13
      Source state
      Current
      Snapshot hash
      8ab438a43402f351d1d4a925cbe1dd4855c4e5a8f29f85e62c6495e53168a53a
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as ce-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2, hash only). The raw record is committed at research/snapshots/ce-openfda-nda202293.json.

    8. Supports openFDA Drugs@FDA record for NDA202293: FARXIGA (dapagliflozin tablets)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA drugsfda record returned on 2026-10-14, from a dataset last updated 2026-10-13. The record lists the application, its products and its submissions. It does not carry indication text. · NDA: NDA202293

      Locator
      results[0].products[0].active_ingredients
      How it applies
      The active ingredients of the product.
      Retrieved
      Source effective date
      2026-10-13
      Source state
      Current
      Snapshot hash
      8ab438a43402f351d1d4a925cbe1dd4855c4e5a8f29f85e62c6495e53168a53a
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as ce-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2, hash only). The raw record is committed at research/snapshots/ce-openfda-nda202293.json.

    9. Background openFDA Drugs@FDA record for NDA202293: FARXIGA (dapagliflozin tablets)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA drugsfda record returned on 2026-10-14, from a dataset last updated 2026-10-13. The record lists the application, its products and its submissions. It does not carry indication text. · NDA: NDA202293

      Locator
      results[0].products[0].dosage_form
      How it applies
      The dosage form of the listed products.
      Retrieved
      Source effective date
      2026-10-13
      Source state
      Current
      Snapshot hash
      8ab438a43402f351d1d4a925cbe1dd4855c4e5a8f29f85e62c6495e53168a53a
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as ce-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2, hash only). The raw record is committed at research/snapshots/ce-openfda-nda202293.json.

    10. Background openFDA Drugs@FDA record for NDA202293: FARXIGA (dapagliflozin tablets)

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition The openFDA drugsfda record returned on 2026-10-14, from a dataset last updated 2026-10-13. The record lists the application, its products and its submissions. It does not carry indication text. · NDA: NDA202293

      Locator
      results[0].openfda.manufacturer_name[0]
      How it applies
      A manufacturer name in the openFDA block of the record.
      Retrieved
      Source effective date
      2026-10-13
      Source state
      Current
      Snapshot hash
      8ab438a43402f351d1d4a925cbe1dd4855c4e5a8f29f85e62c6495e53168a53a
      Reuse basis
      openFDA data is public domain under a Creative Commons CC0 1.0 Universal dedication, as the openFDA licence page states (fetched 2026-10-14 as ce-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2, hash only). The raw record is committed at research/snapshots/ce-openfda-nda202293.json.

Authorization

Regulatory decision: Dapagliflozin (Farxiga)

Applies to Recipient not specified
  • Not stated in the fetched FDA records. They name a product and a sponsor and give no intended population or indication for the original approval.
  • Not stated in the FDA records
  • United States (decision by the US Food and Drug Administration)
  • Not stated in the FDA records
  • Gestational age Not reported
  • Postnatal age Not reported
Follow-up Not applicable (regulatory decision)
Authority
U.S. Food and Drug Administration
Decision
Approval,
Pathway
NDA
Submission
NDA202293
Jurisdictions
United States; note: United States
Product version
Farxiga tablets (dosage form TABLET in the openFDA record)
Indication
Not stated in the fetched FDA records for the original approval
Basis
The US Food and Drug Administration approved New Drug Application NDA202293 for FARXIGA (dapagliflozin) tablets on 8 January 2014. The openFDA record lists the original approval as submission ORIG-1, classified as Type 1 - New Molecular Entity, with standard review priority. The openFDA record names ASTRAZENECA AB as the sponsor of the application.

Limitations. This claim records the original approval and the fields the records give. The records fetched carry no indication text for the original approval, so the claim does not say what the medicine was approved to treat then. The openFDA record also lists later submissions, mostly supplements, and the fetched records do not say which of them changed the approved uses, including for heart failure. Current labelling was not read. An approval is not a finding about how well the medicine works. openFDA's own disclaimer says not to rely on it for decisions about medical care.

A regulatory decision is separate from a guideline recommendation and from payment coverage.

Record details

Record id
cardio:farxiga
Content hash
5140cafc95afeec3f818ad8b42319fe855616dbb74dc69d406347d9947f49bbe