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FDA NDA · NDA211929

ORTIKOS

Sponsor: SUN PHARM INDS INC

APPLICATION
NDA211929
TYPE
NDA
ORIGINAL APPROVAL
2019-06-13
LATEST ACTION
2024-06-05
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED RELEASE
MARKETING STATUS
Discontinued

Products

ORTIKOS · ReferenceDiscontinued
BUDESONIDE 9MG · CAPSULE, DELAYED RELEASE · ORAL
ORTIKOS · ReferenceDiscontinued
BUDESONIDE 6MG · CAPSULE, DELAYED RELEASE · ORAL

Approval history

2024-06-05Labeling · Supplement 11 · standard — Label ↗AP
2022-06-29Labeling · Supplement 8 · standardAP
2019-06-13Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
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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