APPLICATION
ANDA077450
TYPE
ANDA
ORIGINAL APPROVAL
2006-02-10
LATEST ACTION
2024-09-25
ROUTE
INTRAVENOUS, SUBCUTANEOUS, 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
2024-09-25Labeling · Supplement 21 · standardAP
2024-09-25Labeling · Supplement 18 · standardAP
2023-06-30Labeling · Supplement 16 · standardAP
2023-06-30Labeling · Supplement 14 · standardAP
2023-06-30Labeling · Supplement 9 · standardAP
2023-06-30Labeling · Supplement 13 · standardAP
2018-03-09Labeling · Supplement 8 · standardAP
2018-03-09Labeling · Supplement 6 · standardAP
2012-11-30Labeling · Supplement 5 · standardAP
2006-02-10OriginalAP
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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