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FDA NDA · NDA204736

ACIPHEX SPRINKLE

Sponsor: AYTU

APPLICATION
NDA204736
TYPE
NDA
ORIGINAL APPROVAL
2013-03-26
LATEST ACTION
2020-11-27
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED RELEASE
MARKETING STATUS
Discontinued

Products

ACIPHEX SPRINKLE · ReferenceDiscontinued
RABEPRAZOLE SODIUM 5MG · CAPSULE, DELAYED RELEASE · ORAL
ACIPHEX SPRINKLE · ReferenceDiscontinued
RABEPRAZOLE SODIUM 10MG · CAPSULE, DELAYED RELEASE · ORAL

Approval history

2020-11-27Labeling · Supplement 12 · standard — Label ↗AP
2018-06-07Labeling · Supplement 10 · standard — Label ↗AP
2017-07-27Labeling · Supplement 8 · standard — Letter ↗AP
2016-10-24Labeling · Supplement 7 · standard — Letter ↗AP
2016-04-04Labeling · Supplement 3 · standard — Label ↗AP
2015-10-13Manufacturing (CMC) · Supplement 6 · priorityAP
2014-12-19Labeling · Supplement 5 · 901 required — Label ↗AP
2014-10-15Labeling · Supplement 4 · standard — Label ↗AP
2013-08-28Manufacturing (CMC) · Supplement 1 · priorityAP
2013-03-26Type 3 - New Dosage Form · Original · priority — 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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