# Empagliflozin (Jardiance)

Product · id `cardio:jardiance` · Cardiovascular Atlas · release `f6f6f1b6f50379ed` (public)

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Also called: Jardiance; JARDIANCE

Browse, organ or system: Heart  
Browse, condition area: Heart failure  

## In plain language

Jardiance is the brand name of empagliflozin tablets, an SGLT2 inhibitor. The US FDA approved the application on 1 August 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 empagliflozin page.

## Technical summary

FDA application NDA204629. The openFDA record names BOEHRINGER INGELHEIM as the sponsor and Boehringer Ingelheim Pharmaceuticals, Inc. as a manufacturer name in its openFDA block.

## Claims, with the population each applies to

## Context: United States approval record NDA204629 for Jardiance (empagliflozin)

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)

### The US Food and Drug Administration approved New Drug Application NDA204629 for JARDIANCE (empagliflozin) tablets on 1 August 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 BOEHRINGER INGELHEIM as the sponsor of the application.

- Category: Regulatory
- Evidence stage: Evidence stage not applicable
- Certainty: Certainty not assessed
- Applies to: 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)
- 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
- Sources:
  1. Supports: openFDA Drugs@FDA record for NDA204629: JARDIANCE (empagliflozin tablets) (Regulator, 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.) <https://api.fda.gov/drug/drugsfda.json?search=openfda.application_number:%22NDA204629%22&limit=5>
     Locator: results\[0\].application\_number. Retrieved 2026-10-14T18:20:04Z. Source state: Current. Snapshot hash: 56a863613d83d79b83c7fa71962cb93d0713c2753d2fe57d00c44bca6a209317.
     How it applies: The application number of this record.
  2. Supports: Drugs@FDA overview page for NDA 204629 (JARDIANCE) (Regulator, edition Drugs@FDA application overview page fetched 2026-10-14. It lists the original approval date as a month-first slash date.) <https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=204629>
     Locator: Original Approvals or Tentative Approvals table, Action Date (MM/DD/YYYY). Retrieved 2026-10-14T18:27:08Z. Source state: Current. Snapshot hash: bd79424204d115d1a44b16371247d49ac33ad7fc9d6c73cc46339584844fb3a0.
     How it applies: Original approval date and submission ORIG-1. The page writes the date month first; it is used only for the date.
  3. Supports: openFDA Drugs@FDA record for NDA204629: JARDIANCE (empagliflozin tablets) (Regulator, 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.) <https://api.fda.gov/drug/drugsfda.json?search=openfda.application_number:%22NDA204629%22&limit=5>
     Locator: results\[0\].submissions\[14\].submission\_class\_code\_description. Retrieved 2026-10-14T18:20:04Z. Source state: Current. Snapshot hash: 56a863613d83d79b83c7fa71962cb93d0713c2753d2fe57d00c44bca6a209317.
     How it applies: The submission classification of the original approval.
  4. Supports: openFDA Drugs@FDA record for NDA204629: JARDIANCE (empagliflozin tablets) (Regulator, 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.) <https://api.fda.gov/drug/drugsfda.json?search=openfda.application_number:%22NDA204629%22&limit=5>
     Locator: results\[0\].submissions\[14\].review\_priority. Retrieved 2026-10-14T18:20:04Z. Source state: Current. Snapshot hash: 56a863613d83d79b83c7fa71962cb93d0713c2753d2fe57d00c44bca6a209317.
     How it applies: The review priority of the original approval.
  5. Supports: openFDA Drugs@FDA record for NDA204629: JARDIANCE (empagliflozin tablets) (Regulator, 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.) <https://api.fda.gov/drug/drugsfda.json?search=openfda.application_number:%22NDA204629%22&limit=5>
     Locator: results\[0\].submissions\[14\].submission\_status\_date. Retrieved 2026-10-14T18:20:04Z. Source state: Current. Snapshot hash: 56a863613d83d79b83c7fa71962cb93d0713c2753d2fe57d00c44bca6a209317.
     How it applies: The openFDA submission list gives the same original approval date in compact form.
  6. Supports: openFDA Drugs@FDA record for NDA204629: JARDIANCE (empagliflozin tablets) (Regulator, 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.) <https://api.fda.gov/drug/drugsfda.json?search=openfda.application_number:%22NDA204629%22&limit=5>
     Locator: results\[0\].sponsor\_name. Retrieved 2026-10-14T18:20:04Z. Source state: Current. Snapshot hash: 56a863613d83d79b83c7fa71962cb93d0713c2753d2fe57d00c44bca6a209317.
     How it applies: The application sponsor, as the record writes the name.
  7. Supports: openFDA Drugs@FDA record for NDA204629: JARDIANCE (empagliflozin tablets) (Regulator, 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.) <https://api.fda.gov/drug/drugsfda.json?search=openfda.application_number:%22NDA204629%22&limit=5>
     Locator: results\[0\].products\[0\].brand\_name. Retrieved 2026-10-14T18:20:04Z. Source state: Current. Snapshot hash: 56a863613d83d79b83c7fa71962cb93d0713c2753d2fe57d00c44bca6a209317.
     How it applies: The brand name.
  8. Supports: openFDA Drugs@FDA record for NDA204629: JARDIANCE (empagliflozin tablets) (Regulator, 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.) <https://api.fda.gov/drug/drugsfda.json?search=openfda.application_number:%22NDA204629%22&limit=5>
     Locator: results\[0\].products\[0\].active\_ingredients. Retrieved 2026-10-14T18:20:04Z. Source state: Current. Snapshot hash: 56a863613d83d79b83c7fa71962cb93d0713c2753d2fe57d00c44bca6a209317.
     How it applies: The active ingredients of the product.
  9. Background: openFDA Drugs@FDA record for NDA204629: JARDIANCE (empagliflozin tablets) (Regulator, 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.) <https://api.fda.gov/drug/drugsfda.json?search=openfda.application_number:%22NDA204629%22&limit=5>
     Locator: results\[0\].products\[0\].dosage\_form. Retrieved 2026-10-14T18:20:04Z. Source state: Current. Snapshot hash: 56a863613d83d79b83c7fa71962cb93d0713c2753d2fe57d00c44bca6a209317.
     How it applies: The dosage form of the listed products.
  10. Background: openFDA Drugs@FDA record for NDA204629: JARDIANCE (empagliflozin tablets) (Regulator, 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.) <https://api.fda.gov/drug/drugsfda.json?search=openfda.application_number:%22NDA204629%22&limit=5>
     Locator: results\[0\].openfda.manufacturer\_name\[0\]. Retrieved 2026-10-14T18:20:04Z. Source state: Current. Snapshot hash: 56a863613d83d79b83c7fa71962cb93d0713c2753d2fe57d00c44bca6a209317.
     How it applies: A manufacturer name in the openFDA block of the record.

## Guidance, authorization and access

### Regulatory decision `cardio:regdec-fda-nda204629`

- Product: Empagliflozin (Jardiance) (`cardio:jardiance`)
- Authority: U.S. Food and Drug Administration (`core:fda`)
- Decision: Approval, 2014-08-01
- Product version: Jardiance tablets (dosage form TABLET in the openFDA record)
- Pathway: NDA
- Submission: NDA204629
- Indication: Not stated in the fetched FDA records for the original approval
- Jurisdictions: United States; note: United States
- Applies to: 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)
- Basis: claim `cardio:claim-fda-nda204629-approval`

## Connected pages

- Active ingredient of Jardiance: Empagliflozin (`cardio:empagliflozin`)
- The openFDA record names Boehringer Ingelheim Pharmaceuticals, Inc. as a manufacturer; the application sponsor is BOEHRINGER INGELHEIM: Boehringer Ingelheim (`cardio:boehringer-ingelheim`)
- Files under this front: Medicines (`cardio:front-medicines`)

## Provenance

Content hash: 99b22a79cc0bdb3193d1a37b721d3d14cb47a76606e843ec747a9720900f9fc0
Last substantive edit: 2026-10-14
Evidence last checked: 2026-10-14