Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206759
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 | 8MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB2 | No | No |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB2 | 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 |
|---|---|---|---|---|---|---|---|
| 08/09/2016 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
POTASSIUM CHLORIDE
TABLET, EXTENDED RELEASE;ORAL; 8MEQ
TE Code = AB2
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| KLOR-CON | POTASSIUM CHLORIDE | 8MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB2 | 019123 | UPSHER SMITH LABS |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 8MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 210921 | AUROBINDO PHARMA LTD |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 8MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 211797 | GRANULES |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 8MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 204662 | MYLAN |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 8MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 206759 | NOVEL LABS INC |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 8MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 205993 | PADAGIS US |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 8MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 207528 | SIGMAPHARM LABS LLC |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 8MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 210733 | STRIDES PHARMA |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 8MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 209314 | YICHANG HUMANWELL |
TABLET, EXTENDED RELEASE;ORAL; 10MEQ
TE Code = AB2
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| KLOR-CON | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB2 | 019123 | UPSHER SMITH LABS |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 210921 | AUROBINDO PHARMA LTD |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 211797 | GRANULES |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 204662 | MYLAN |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 206759 | NOVEL LABS INC |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 205993 | PADAGIS US |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 207528 | SIGMAPHARM LABS LLC |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 210733 | STRIDES PHARMA |
| POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 10MEQ | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB2 | 209314 | YICHANG HUMANWELL |
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