Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 209786
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/15ML | SOLUTION;ORAL | Prescription | AA | No | No |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 40MEQ/15ML | 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 |
---|---|---|---|---|---|---|---|
08/29/2018 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/19/2022 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
01/30/2020 | SUPPL-2 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
POTASSIUM CHLORIDE
SOLUTION;ORAL; 20MEQ/15ML
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 20MEQ/15ML | SOLUTION;ORAL | Prescription | No | AA | 210041 | AMNEAL |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 20MEQ/15ML | SOLUTION;ORAL | Prescription | No | AA | 214892 | ANDA REPOSITORY |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 20MEQ/15ML | SOLUTION;ORAL | Prescription | No | AA | 211067 | APOTEX |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 20MEQ/15ML | SOLUTION;ORAL | Prescription | No | AA | 216156 | BELCHER |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 20MEQ/15ML | SOLUTION;ORAL | Prescription | Yes | AA | 206814 | GENUS LIFESCIENCES |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 20MEQ/15ML | SOLUTION;ORAL | Prescription | No | AA | 213392 | GRANULES |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 20MEQ/15ML | SOLUTION;ORAL | Prescription | No | AA | 209786 | NOVEL LABS INC |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 20MEQ/15ML | SOLUTION;ORAL | Prescription | No | AA | 210766 | PHARM ASSOC |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 20MEQ/15ML | SOLUTION;ORAL | Prescription | No | AA | 214656 | RUBICON |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 20MEQ/15ML | SOLUTION;ORAL | Prescription | No | AA | 211648 | SAPTALIS PHARMS |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 20MEQ/15ML | SOLUTION;ORAL | Prescription | No | AA | 211665 | STRIDES PHARMA |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 20MEQ/15ML | SOLUTION;ORAL | Prescription | No | AA | 213062 | WES PHARMA INC |
SOLUTION;ORAL; 40MEQ/15ML
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 40MEQ/15ML | SOLUTION;ORAL | Prescription | No | AA | 210041 | AMNEAL |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 40MEQ/15ML | SOLUTION;ORAL | Prescription | No | AA | 214892 | ANDA REPOSITORY |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 40MEQ/15ML | SOLUTION;ORAL | Prescription | No | AA | 211067 | APOTEX |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 40MEQ/15ML | SOLUTION;ORAL | Prescription | No | AA | 216156 | BELCHER |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 40MEQ/15ML | SOLUTION;ORAL | Prescription | Yes | AA | 206814 | GENUS LIFESCIENCES |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 40MEQ/15ML | SOLUTION;ORAL | Prescription | No | AA | 213392 | GRANULES |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 40MEQ/15ML | SOLUTION;ORAL | Prescription | No | AA | 209786 | NOVEL LABS INC |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 40MEQ/15ML | SOLUTION;ORAL | Prescription | No | AA | 210766 | PHARM ASSOC |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 40MEQ/15ML | SOLUTION;ORAL | Prescription | No | AA | 214656 | RUBICON |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 40MEQ/15ML | SOLUTION;ORAL | Prescription | No | AA | 211648 | SAPTALIS PHARMS |
POTASSIUM CHLORIDE | POTASSIUM CHLORIDE | 40MEQ/15ML | SOLUTION;ORAL | Prescription | No | AA | 213062 | WES PHARMA INC |