Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 218979
Company: TWI PHARMS

Products on ANDA 218979

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB2	No	No
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB2	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 218979

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/28/2024	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
10/27/2025	SUPPL-3	Labeling-Proprietary Name Change		Label is not available on this site.

Therapeutic Equivalents for ANDA 218979

POTASSIUM CHLORIDE

TABLET, EXTENDED RELEASE;ORAL; 8MEQ
TE Code = AB2

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
KLOR-CON	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB2	019123	UPSHER SMITH LABS
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB2	210921	AUROBINDO PHARMA
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB2	211797	GRANULES
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB2	212987	MACLEODS PHARMS LTD
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB2	206759	NOVEL LABS INC
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB2	205993	PADAGIS US
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB2	204662	PHARMOBEDIENT
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB2	217412	RISING
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB2	210733	STRIDES PHARMA
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB2	218979	TWI PHARMS
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	8MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB2	209314	YICHANG HUMANWELL

TABLET, EXTENDED RELEASE;ORAL; 10MEQ
TE Code = AB2

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
KLOR-CON	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB2	019123	UPSHER SMITH LABS
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB2	210921	AUROBINDO PHARMA
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB2	211797	GRANULES
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB2	212987	MACLEODS PHARMS LTD
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB2	206759	NOVEL LABS INC
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB2	205993	PADAGIS US
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB2	204662	PHARMOBEDIENT
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB2	217412	RISING
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB2	210733	STRIDES PHARMA
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB2	218979	TWI PHARMS
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB2	209314	YICHANG HUMANWELL