Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 208019
Company: PHARMA RES SOFTWARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 20MEQ FOR SOLUTION;ORAL Prescription AA Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/19/2015 ORIG-1 Approval Type 7 - Drug Already Marketed without Approved NDA STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/208019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/208019Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/208019Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/208019Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/10/2019 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208019s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208019Orig1s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/10/2019 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208019s002lbl.pdf
08/19/2015 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/208019lbl.pdf

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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