← FDA DRUG APPROVALS

FDA NDA · NDA021314

IDKIT HP ONE

citric acid anhydrous and 13c urea

Sponsor: MERIDIAN BIOSCIENCE

APPLICATION
NDA021314
TYPE
NDA
ORIGINAL APPROVAL
2002-12-17
LATEST ACTION
2026-07-24
ROUTE
ORAL
DOSAGE FORM
FOR SOLUTION, TABLET, FOR SOLUTION
MARKETING STATUS
Prescription

Products

IDKIT:HP · ReferencePrescription
CITRIC ACID 4GM, UREA C-13 75MG · FOR SOLUTION, TABLET, FOR SOLUTION · ORAL

Approval history

2026-07-24Efficacy · Supplement 14 · standard — Letter ↗AP
2016-07-25Manufacturing (CMC) · Supplement 6 · standardAP
2016-07-08Manufacturing (CMC) · Supplement 5 · standard — Letter ↗AP
2014-10-28Labeling · Supplement 4 · standard — Label ↗AP
2013-01-18Manufacturing (CMC) · Supplement 3 · standardAP
2010-02-26Labeling · Supplement 2 · standardAP
2002-12-17Type 3 - New Dosage Form · Original · standard — 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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