APPLICATION
ANDA204669
TYPE
ANDA
ORIGINAL APPROVAL
2018-12-27
LATEST ACTION
2024-07-09
ROUTE
INTRAVENOUS, SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
OCTREOTIDE ACETATEPrescription
OCTREOTIDE ACETATE EQ 0.1MG BASE/ML · INJECTABLE · INJECTION
OCTREOTIDE ACETATEPrescription
OCTREOTIDE ACETATE EQ 0.5MG BASE/ML · INJECTABLE · INJECTION
OCTREOTIDE ACETATEPrescription
OCTREOTIDE ACETATE EQ 0.05MG BASE/ML · INJECTABLE · INJECTION
Approval history
2024-07-09Labeling · Supplement 6 · standardAP
2023-02-21Labeling · Supplement 2 · standardAP
2023-02-21Labeling · Supplement 3 · standardAP
2020-02-03Labeling · Supplement 1 · standardAP
2018-12-27UNKNOWN · 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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