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FDA NDA · NDA021324

BUDESONIDE

Sponsor: PADAGIS US

APPLICATION
NDA021324
TYPE
NDA
ORIGINAL APPROVAL
2001-10-02
LATEST ACTION
2024-06-05
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED RELEASE
MARKETING STATUS
Prescription

Products

ENTOCORT EC · ReferencePrescription
BUDESONIDE 3MG · CAPSULE, DELAYED RELEASE · ORAL

Approval history

2024-06-05Labeling · Supplement 27 · standard — Label ↗AP
2020-07-15Labeling · Supplement 23 · standard — Label ↗AP
2019-01-18Labeling · Supplement 18 · standard — Label ↗AP
2017-10-17Labeling · Supplement 16 · standard — Label ↗AP
2016-04-29Efficacy · Supplement 13 · standard — Letter ↗AP
2016-04-29Efficacy · Supplement 12 · standard — Pediatric Medical Review ↗AP
2011-12-20Labeling · Supplement 9 · unknown — Label ↗AP
2009-06-22Labeling · Supplement 8 · standard — Letter ↗AP
2005-04-29Efficacy · Supplement 5 · unknown — Label ↗AP
2003-03-13Manufacturing (CMC) · Supplement 4 · priority — Letter ↗AP
2002-10-03Manufacturing (CMC) · Supplement 3 · priority — Letter ↗AP
2002-08-14Manufacturing (CMC) · Supplement 2 · priorityAP
2002-08-09Manufacturing (CMC) · Supplement 1 · priority — Letter ↗AP
2001-10-02Type 3 - New Dosage Form · Original · priority — Pediatric Medical Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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