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FDA NDA · NDA020314

OCTREOSCAN

indium in -111 pentetreotide

Sponsor: CURIUM

APPLICATION
NDA020314
TYPE
NDA
ORIGINAL APPROVAL
1994-06-02
LATEST ACTION
2022-02-09
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

OCTREOSCAN · ReferencePrescription
INDIUM IN-111 PENTETREOTIDE KIT 3mCi/ML · INJECTABLE · INJECTION

Approval history

2022-02-09Labeling · Supplement 12 · standard — Letter ↗AP
2021-12-22Labeling · Supplement 14 · standard — Letter ↗AP
1998-04-08Manufacturing (CMC) · Supplement 2 · priorityAP
1994-12-08Manufacturing (CMC) · Supplement 1 · priorityAP
1994-06-02Type 1 - New Molecular Entity · Original · priorityAP
VIEW ON DRUGS@FDA ↗

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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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