Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209786
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
01/30/2020 SUPPL-2 Labeling-Package Insert, Labeling-Container/Carton Labels

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 211067 APOTEX
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 211648 SAPTALIS PHARMS

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 211067 APOTEX
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 211648 SAPTALIS PHARMS

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