Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210241
Company: NOVEL LABS INC

Products on ANDA 210241

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 210241

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/21/2018	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
06/19/2020	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
06/19/2020	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 210241

POTASSIUM CHLORIDE

FOR SOLUTION;ORAL; 20MEQ
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
KLOR-CON	POTASSIUM CHLORIDE	20MEQ	FOR SOLUTION;ORAL	Prescription	No	AA	209662	UPSHER SMITH LABS
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	20MEQ	FOR SOLUTION;ORAL	Prescription	No	AA	210902	AMNEAL
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	20MEQ	FOR SOLUTION;ORAL	Prescription	No	AA	212183	BELCHER
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	20MEQ	FOR SOLUTION;ORAL	Prescription	No	AA	210200	EPIC PHARMA LLC
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	20MEQ	FOR SOLUTION;ORAL	Prescription	No	AA	213467	GRANULES
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	20MEQ	FOR SOLUTION;ORAL	Prescription	No	AA	210241	NOVEL LABS INC
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	20MEQ	FOR SOLUTION;ORAL	Prescription	No	AA	212816	NOVITIUM PHARMA
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	20MEQ	FOR SOLUTION;ORAL	Prescription	Yes	AA	208019	PHARMA RES SOFTWARE
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	20MEQ	FOR SOLUTION;ORAL	Prescription	No	AA	214108	RUBICON
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	20MEQ	FOR SOLUTION;ORAL	Prescription	No	AA	211667	STRIDES PHARMA