APPLICATION
ANDA075957
TYPE
ANDA
ORIGINAL APPROVAL
2005-10-03
LATEST ACTION
2023-08-08
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
2023-08-08Labeling · Supplement 32 · standardAP
2023-08-08Labeling · Supplement 35 · standardAP
2023-08-08Labeling · Supplement 33 · standardAP
2019-11-04Labeling · Supplement 28 · standardAP
2017-06-27Labeling · Supplement 25 · standardAP
2012-06-28Labeling · Supplement 13 · standardAP
2012-06-28Labeling · Supplement 11AP
2005-10-03OriginalAP
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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