Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 206814
Company: GENUS LIFESCIENCES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION;ORAL Prescription AA Yes No
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 40MEQ/15ML 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
12/22/2014 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/2014/206814lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206814Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206814Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206814Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/07/2019 SUPPL-8 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206814s008lbl.pdf
02/04/2019 SUPPL-7 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206814s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/206814Orig1s007ltr_.pdf
07/14/2015 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/07/2019 SUPPL-8 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206814s008lbl.pdf
02/04/2019 SUPPL-7 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206814s007lbl.pdf
02/04/2019 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206814s007lbl.pdf
12/22/2014 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206814lbl.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
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 20MEQ/15ML SOLUTION;ORAL Prescription No AA 210766 PHARM ASSOC

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
POTASSIUM CHLORIDE POTASSIUM CHLORIDE 40MEQ/15ML SOLUTION;ORAL Prescription No AA 210766 PHARM ASSOC

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English