FDA ANDA · ANDA206697

EXENATIDE

Sponsor: AMNEAL

What this page does not claim

A drug page is a reference view of public FDA data (Drugs@FDA), reproduced as published. SPEQ is not affiliated with the FDA, adds no interpretation to the record, and nothing here is medical, legal, or regulatory advice.

APPLICATION
ANDA206697
TYPE
ANDA
ORIGINAL APPROVAL
2024-11-19
LATEST ACTION
2026-10-02
ROUTE
SUBCUTANEOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

EXENATIDE SYNTHETICDiscontinued
EXENATIDE SYNTHETIC 300MCG/1.2ML (250MCG/ML) · INJECTABLE · SUBCUTANEOUS
EXENATIDE SYNTHETICDiscontinued
EXENATIDE SYNTHETIC 600MCG/2.4ML (250MCG/ML) · INJECTABLE · SUBCUTANEOUS

Approval history

2026-10-02Labeling · Supplement 6 · standardAP
2026-10-02Labeling · Supplement 9 · standardAP
2026-10-02Labeling · Supplement 7 · standardAP
2024-11-19UNKNOWN · Original · standardAP