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 |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
12/17/2002 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21314_BreathID_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21314ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021314s000_IDKitTOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/25/2016 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/08/2016 | SUPPL-5 | Manufacturing (CMC) |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021314Orig1s005ltr.pdf |
10/28/2014 | SUPPL-4 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021314s004.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021314Orig1s004ltr.pdf | |
01/18/2013 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/26/2010 | SUPPL-2 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
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 |