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Drugs@FDA: FDA-Approved Drugs

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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
POKONZA	POTASSIUM CHLORIDE	10MEQ/15ML	SOLUTION;ORAL	Prescription	None	Yes	No
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.html 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
06/12/2026	SUPPL-13	Manufacturing (CMC)-New Strength	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/206814Orig1s013lbl.pdf
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
06/12/2026	SUPPL-13	Manufacturing (CMC)-New Strength	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/206814Orig1s013lbl.pdf
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

POKONZA

There are no Therapeutic Equivalents.

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	216156	AJENAT PHARMS
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	211992	ASCENT PHARMS INC
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION;ORAL	Prescription	No	AA	216536	AUROBINDO PHARMA
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	218733	MACLEODS PHARMS LTD
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	215716	QUAGEN
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION;ORAL	Prescription	No	AA	214656	RUBICON RESEARCH
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION;ORAL	Prescription	No	AA	211648	SCIEGEN 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	218960	TARO
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	216156	AJENAT PHARMS
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	211992	ASCENT PHARMS INC
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION;ORAL	Prescription	No	AA	216536	AUROBINDO PHARMA
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	218733	MACLEODS PHARMS LTD
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	215716	QUAGEN
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION;ORAL	Prescription	No	AA	214656	RUBICON RESEARCH
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION;ORAL	Prescription	No	AA	211648	SCIEGEN PHARMS
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION;ORAL	Prescription	No	AA	213062	WES PHARMA INC

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