Anaphylaxis

• FDA label_change · 2026-03-20
  FDA Approved: EPIPEN — Supplemental Application (Viatris Specialty LLC)

  FDA approves a supplemental application for EPIPEN (epinephrine) by Viatris Specialty LLC, indicating changes to the product labeling.

• FDA label_change · 2025-04-30
  FDA Approved: AUVI-Q — Supplemental Application (kaleo, Inc)

  FDA approved a supplemental application for AUVI-Q (epinephrine auto-injector) from Kaleo, Inc., likely reflecting labeling changes.

• FDA label_change · 2024-02-28
  FDA Approved: AUVI-Q — Supplemental Application (kaleo, Inc)

  FDA approved a supplemental labeling application for AUVI-Q (epinephrine auto-injector) submitted by Kaleo, Inc., resulting in updated produ…

• FDA label_change · 2018-08-23
  FDA Approved: EPIPEN — Supplemental Application (Viatris Specialty LLC)

  FDA approved a supplemental application for EPIPEN (epinephrine autoinjector) from Viatris Specialty LLC, resulting in changes to the produc…

• FDA label_change · 2016-09-12
  FDA Approved: ADRENALIN — Supplemental Application (Par Health USA, LLC)

  FDA approves a supplemental labeling application for Adrenalin (epinephrine) submitted by Par Health USA, LLC.

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA label_change · 2016-05-18
  FDA Approved: EPINEPHRINE — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved a supplemental application for epinephrine from Amneal Pharmaceuticals of New York LLC, indicating a labeling change for the pr…