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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209688
Company: TWI PHARMS

Products on ANDA 209688

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB3	No	No
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB3	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 209688

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/12/2018	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
02/01/2021	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 209688

POTASSIUM CHLORIDE

TABLET, EXTENDED RELEASE;ORAL; 10MEQ
TE Code = AB3

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB3	215725	RUBICON RESEARCH
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB3	209688	TWI PHARMS
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	10MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB3	212561	YICHANG HUMANWELL

TABLET, EXTENDED RELEASE;ORAL; 20MEQ
TE Code = AB3

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB3	215725	RUBICON RESEARCH
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB3	209688	TWI PHARMS
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	20MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB3	212561	YICHANG HUMANWELL

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