APPLICATION
ANDA076330
TYPE
ANDA
ORIGINAL APPROVAL
2005-04-08
LATEST ACTION
2022-09-16
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
2022-09-16Labeling · Supplement 16 · standardAP
2022-09-16Labeling · Supplement 20 · standardAP
2022-09-16Labeling · Supplement 18 · standardAP
2018-08-27Labeling · Supplement 13 · standardAP
2012-09-12Labeling · Supplement 9 · standardAP
2009-03-03Labeling · Supplement 4AP
2005-04-08OriginalAP
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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