Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 209662
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 | 20MEQ | FOR SOLUTION;ORAL | Prescription | AA | 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 |
|---|---|---|---|---|---|---|---|
| 10/23/2017 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209662Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/26/2022 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/06/2020 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
KLOR-CON
FOR SOLUTION;ORAL; 20MEQ
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| KLOR-CON | POTASSIUM CHLORIDE | 20MEQ | FOR SOLUTION;ORAL | Prescription | No | AA | 209662 | UPSHER SMITH LABS |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 20MEQ | FOR SOLUTION;ORAL | Prescription | No | AA | 210902 | AMNEAL |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 20MEQ | FOR SOLUTION;ORAL | Prescription | No | AA | 212183 | BELCHER |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 20MEQ | FOR SOLUTION;ORAL | Prescription | No | AA | 210200 | EPIC PHARMA LLC |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 20MEQ | FOR SOLUTION;ORAL | Prescription | Yes | AA | 208019 | GENUS |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 20MEQ | FOR SOLUTION;ORAL | Prescription | No | AA | 213467 | GRANULES |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 20MEQ | FOR SOLUTION;ORAL | Prescription | No | AA | 210241 | NOVEL LABS INC |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 20MEQ | FOR SOLUTION;ORAL | Prescription | No | AA | 212816 | NOVITIUM PHARMA |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 20MEQ | FOR SOLUTION;ORAL | Prescription | No | AA | 214108 | RUBICON |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 20MEQ | FOR SOLUTION;ORAL | Prescription | No | AA | 211667 | STRIDES PHARMA |