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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205993
Company: PADAGIS US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 8MEQ TABLET, EXTENDED RELEASE;ORAL Prescription AB2 No No
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 10MEQ TABLET, EXTENDED RELEASE;ORAL Prescription AB2 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
11/05/2015 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
04/26/2020 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

POTASSIUM CHLORIDE

TABLET, EXTENDED RELEASE;ORAL; 8MEQ
TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
KLOR-CON POTASSIUM CHLORIDE 8MEQ TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB2 019123 UPSHER SMITH LABS
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 8MEQ TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 210921 AUROBINDO PHARMA
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 8MEQ TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 211797 GRANULES
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 8MEQ TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 204662 MYLAN
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 8MEQ TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 206759 NOVEL LABS INC
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 8MEQ TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 205993 PADAGIS US
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 8MEQ TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 210733 STRIDES PHARMA
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 8MEQ TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 209314 YICHANG HUMANWELL

TABLET, EXTENDED RELEASE;ORAL; 10MEQ
TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
KLOR-CON POTASSIUM CHLORIDE 10MEQ TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB2 019123 UPSHER SMITH LABS
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 10MEQ TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 210921 AUROBINDO PHARMA
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 10MEQ TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 211797 GRANULES
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 10MEQ TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 204662 MYLAN
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 10MEQ TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 206759 NOVEL LABS INC
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 10MEQ TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 205993 PADAGIS US
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 10MEQ TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 210733 STRIDES PHARMA
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 10MEQ TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 209314 YICHANG HUMANWELL
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