← FDA DRUG APPROVALS

FDA ANDA · ANDA206697

EXENATIDE

Sponsor: AMNEAL

APPLICATION
ANDA206697
TYPE
ANDA
ORIGINAL APPROVAL
2024-11-19
LATEST ACTION
2024-11-19
ROUTE
SUBCUTANEOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

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

Approval history

2024-11-19UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA enforcement & recalls

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →