APPLICATION
ANDA075959
TYPE
ANDA
ORIGINAL APPROVAL
2005-11-21
LATEST ACTION
2023-08-08
ROUTE
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
2023-08-08Labeling · Supplement 36 · standardAP
2023-08-08Labeling · Supplement 34 · standardAP
2023-08-08Labeling · Supplement 33 · standardAP
2019-11-04Labeling · Supplement 29 · standardAP
2017-06-27Labeling · Supplement 26 · standardAP
2012-07-12Labeling · Supplement 13 · standardAP
2012-07-12Labeling · Supplement 12AP
2005-11-21OriginalAP
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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