APPLICATION
ANDA076313
TYPE
ANDA
ORIGINAL APPROVAL
2005-03-28
LATEST ACTION
2022-09-16
ROUTE
INTRAVENOUS, SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
OCTREOTIDE ACETATE (PRESERVATIVE FREE)Prescription
OCTREOTIDE ACETATE EQ 0.5MG BASE/ML · INJECTABLE · INJECTION
OCTREOTIDE ACETATE (PRESERVATIVE FREE)Prescription
OCTREOTIDE ACETATE EQ 0.1MG BASE/ML · INJECTABLE · INJECTION
OCTREOTIDE ACETATE (PRESERVATIVE FREE)Prescription
OCTREOTIDE ACETATE EQ 0.05MG BASE/ML · INJECTABLE · INJECTION
Approval history
2022-09-16Labeling · Supplement 19 · standardAP
2022-09-16Labeling · Supplement 21 · standardAP
2022-09-16Labeling · Supplement 16 · standardAP
2018-08-27Manufacturing (CMC) · Supplement 13 · unknownAP
2018-08-27Labeling · Supplement 12 · standardAP
2013-01-02Labeling · Supplement 8 · standardAP
2009-03-03Labeling · Supplement 3AP
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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