RecallHawk

FARXIGA (DAPAGLIFLOZIN)

ASTRAZENECA AB

Summary

FDA approved FARXIGA (DAPAGLIFLOZIN) by ASTRAZENECA AB. NDA (New Drug) approval (Labeling) on 2026-06-03. TABLET, ORAL.

Details

Source

Drug Approval

External ID

NDA202293-35

Action Date

2026-06-03

Status

Approved

Category

drug

Product Code

NDA (New Drug)

Product Description

FARXIGA (generic: DAPAGLIFLOZIN), TABLET, ORAL. Application: NDA202293

Context & Analysis

ASTRAZENECA AB has 10 FDA actions in our database.

Frequently Asked Questions

How often does ASTRAZENECA AB have FDA actions?

ASTRAZENECA AB has 10 FDA actions in our database, including 0 recalls and 0 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "NDA202293-35" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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