Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 209688
Company: VITRUVIAS THERAP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 10MEQ TABLET, EXTENDED RELEASE;ORAL Prescription AB3 No No
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 20MEQ TABLET, EXTENDED RELEASE;ORAL Prescription AB3 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
01/12/2018 ORIG-1 Approval STANDARD

Label is not available on this site.

POTASSIUM CHLORIDE

TABLET, EXTENDED RELEASE;ORAL; 10MEQ
TE Code = AB3

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
K-TAB POTASSIUM CHLORIDE 10MEQ TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB3 018279 ABBVIE
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 10MEQ TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 210097 BRECKENRIDGE
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 10MEQ TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 209688 VITRUVIAS THERAP
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 10MEQ TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 212561 YICHANG HUMANWELL

TABLET, EXTENDED RELEASE;ORAL; 20MEQ
TE Code = AB3

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
K-TAB POTASSIUM CHLORIDE 20MEQ TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB3 018279 ABBVIE
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 20MEQ TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 210098 BRECKENRIDGE
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 20MEQ TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 209688 VITRUVIAS THERAP
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 20MEQ TABLET, EXTENDED RELEASE;ORAL Prescription No AB3 212561 YICHANG HUMANWELL

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