Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211648
Company: SAPTALIS PHARMS

Products on ANDA 211648

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION;ORAL	Prescription	AA	No	No
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211648

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/21/2021	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
01/05/2024	SUPPL-8	Labeling		Label is not available on this site.
01/05/2024	SUPPL-7	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 211648

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