Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020900
Company: DXS DEVICES
Company: DXS DEVICES
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PYLORI-CHEK BREATH TEST | UREA C-13 | 100MG/VIAL | FOR SOLUTION;ORAL | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 02/04/1999 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20900lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20900ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20900_Pylori-Chek.cfm |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/04/1999 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20900lbl.pdf |