Federal Register NoticeMulti-specialty

FDA Approval: FARXIGA (DAPAGLIFLOZIN) — Type 1 - New Molecular Entity

FDA-NDA202293

Document details

Document type
Federal Register Notice
Issuing body
Office of the Federal Register / NARA
Document ID
FDA-NDA202293
Published
June 6, 2026
Effective date
January 8, 2014
MAC region
National

Summary

New FDA approval: FARXIGA (DAPAGLIFLOZIN) by AstraZeneca Pharmaceuticals LP. Oral — likely Part D.

FARXIGA (DAPAGLIFLOZIN) approved 2014-01-08

Affected specialty

Multi-specialty alerts →

Source document

http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202293s000lbl.pdf

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