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FDA NDA · NDA208232

MYCAPSSA

octreotide

Sponsor: CHIESI

APPLICATION
NDA208232
TYPE
NDA
ORIGINAL APPROVAL
2020-06-26
LATEST ACTION
2024-07-11
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED RELEASE
MARKETING STATUS
Prescription

Products

MYCAPSSA · ReferencePrescription
OCTREOTIDE ACETATE EQ 20MG BASE · CAPSULE, DELAYED RELEASE · ORAL

Approval history

2024-07-11Labeling · Supplement 6 · standard — Letter ↗AP
2020-06-26Type 5 - New Formulation or New Manufacturer · Original · standard — Letter ↗AP
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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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