Drugs@FDA: FDA Approved Drug Products
Abbreviated New Drug Application (ANDA): 210241
Company: NOVEL LABS INC
Company: NOVEL LABS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| POTASSIUM CHLORIDE | 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 |
|---|---|---|---|---|---|---|---|
| 11/21/2018 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
POTASSIUM CHLORIDE
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 PHARMS LLC |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 20MEQ | FOR SOLUTION;ORAL | Prescription | No | AA | 212183 | BELCHER PHARMS LLC |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 20MEQ | FOR SOLUTION;ORAL | Prescription | No | AA | 210200 | EPIC PHARMA LLC |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 20MEQ | FOR SOLUTION;ORAL | Prescription | No | AA | 210241 | NOVEL LABS INC |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 20MEQ | FOR SOLUTION;ORAL | Prescription | Yes | AA | 208019 | PHARMA RES SOFTWARE |
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