Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019123
Company: UPSHER SMITH LABS
Company: UPSHER SMITH LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| KLOR-CON | POTASSIUM CHLORIDE | 8MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB2 | Yes | No |
| KLOR-CON | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB2 | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/30/2018 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019123s036lbl.pdf | |
| 01/02/2007 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019123s027lbl.pdf | |
| 01/02/2007 | SUPPL-27 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019123s027lbl.pdf |