An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 206814
Company: GENUS LIFESCIENCES

Summary Review

Products on NDA 206814

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 206814

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
03/05/2020	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206814s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/206814Orig1s009ltr.pdf
05/01/2019	SUPPL-8	Manufacturing (CMC)	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206814s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/206814Orig1s008ltr.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.

Labels for NDA 206814

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/05/2020	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206814s009lbl.pdf
05/01/2019	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

Therapeutic Equivalents for NDA 206814

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
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION;ORAL	Prescription	No	AA	214892	ANDA REPOSITORY
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION;ORAL	Prescription	No	AA	211067	APOTEX
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION;ORAL	Prescription	No	AA	216156	BELCHER
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	213392	GRANULES
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
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION;ORAL	Prescription	No	AA	214656	RUBICON
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION;ORAL	Prescription	No	AA	211648	SAPTALIS PHARMS
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION;ORAL	Prescription	No	AA	211665	STRIDES PHARMA
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION;ORAL	Prescription	No	AA	213062	WES PHARMA INC

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
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION;ORAL	Prescription	No	AA	214892	ANDA REPOSITORY
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION;ORAL	Prescription	No	AA	211067	APOTEX
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION;ORAL	Prescription	No	AA	216156	BELCHER
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	213392	GRANULES
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
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION;ORAL	Prescription	No	AA	214656	RUBICON
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION;ORAL	Prescription	No	AA	211648	SAPTALIS PHARMS
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION;ORAL	Prescription	No	AA	213062	WES PHARMA INC

Top