Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021314
Company: MERIDIAN BIOSCIENCE
Company: MERIDIAN BIOSCIENCE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| IDKIT:HP | CITRIC ACID; UREA C-13 | 4GM;75MG | FOR SOLUTION, TABLET, FOR SOLUTION;ORAL | Prescription | None | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/24/2026 | SUPPL-14 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/021314s014lbl.pdf | |
| 10/28/2014 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021314s004.pdf | |
| 12/17/2002 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21314_BreathID_lbl.pdf |