APPLICATION
ANDA091041
TYPE
ANDA
ORIGINAL APPROVAL
2013-11-12
LATEST ACTION
2019-08-27
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
OCTREOTIDE ACETATEPrescription
OCTREOTIDE ACETATE EQ 0.2MG BASE/ML · INJECTABLE · INJECTION
OCTREOTIDE ACETATEPrescription
OCTREOTIDE ACETATE EQ 1MG BASE/ML · INJECTABLE · INJECTION
Approval history
2019-08-27Labeling · Supplement 5 · standardAP
2017-07-10Labeling · Supplement 3 · standardAP
2013-11-12OriginalAP
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
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.