Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 211067
Company: APOTEX 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
08/08/2018 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/211067Orig1s000ltr.pdf

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 PHARMS LLC
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION;ORAL Prescription No AA 211067 APOTEX INC
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 209786 NOVEL LABS 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 PHARMS LLC
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION;ORAL Prescription No AA 211067 APOTEX INC
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 209786 NOVEL LABS INC

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