Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210241
Company: NOVEL LABS INC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 20MEQ FOR 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
11/21/2018 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
06/19/2020 SUPPL-3 Labeling-Package Insert

Label is not available on this site.
06/19/2020 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

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
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 20MEQ FOR SOLUTION;ORAL Prescription No AA 212183 BELCHER
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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