APPLICATION
ANDA216589
TYPE
ANDA
ORIGINAL APPROVAL
2025-12-12
LATEST ACTION
2025-12-12
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
OCTREOTIDE ACETATEPrescription
OCTREOTIDE ACETATE EQ 30MG BASE/VIAL · INJECTABLE · INJECTION
OCTREOTIDE ACETATEPrescription
OCTREOTIDE ACETATE EQ 10MG BASE/VIAL · INJECTABLE · INJECTION
OCTREOTIDE ACETATEPrescription
OCTREOTIDE ACETATE EQ 20MG BASE/VIAL · INJECTABLE · INJECTION
Approval history
2025-12-12UNKNOWN · Original · standardAP
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.
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