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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214426
Company: HIBROW HLTHCARE

Products on ANDA 214426

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
POTASSIUM CITRATE	POTASSIUM CITRATE	5MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No
POTASSIUM CITRATE	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No
POTASSIUM CITRATE	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 214426

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/19/2021	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
03/31/2022	SUPPL-4	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 214426

POTASSIUM CITRATE

TABLET, EXTENDED RELEASE;ORAL; 5MEQ
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
POTASSIUM CITRATE	POTASSIUM CITRATE	5MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	214420	ASCENT PHARMS INC
POTASSIUM CITRATE	POTASSIUM CITRATE	5MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	214426	HIBROW HLTHCARE
POTASSIUM CITRATE	POTASSIUM CITRATE	5MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	077440	RISING
POTASSIUM CITRATE	POTASSIUM CITRATE	5MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	206813	STRIDES PHARMA
POTASSIUM CITRATE	POTASSIUM CITRATE	5MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	209758	TEVA PHARMS USA INC
POTASSIUM CITRATE	POTASSIUM CITRATE	5MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	203546	ZYDUS PHARMS
UROCIT-K	POTASSIUM CITRATE	5MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	019071	MISSION PHARMA

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

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
POTASSIUM CITRATE	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	212779	ANI PHARMS
POTASSIUM CITRATE	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	214420	ASCENT PHARMS INC
POTASSIUM CITRATE	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	212799	BIONPHARMA
POTASSIUM CITRATE	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	214426	HIBROW HLTHCARE
POTASSIUM CITRATE	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	077440	RISING
POTASSIUM CITRATE	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	206813	STRIDES PHARMA
POTASSIUM CITRATE	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	209758	TEVA PHARMS USA INC
POTASSIUM CITRATE	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	203546	ZYDUS PHARMS
UROCIT-K	POTASSIUM CITRATE	10MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	019071	MISSION PHARMA

TABLET, EXTENDED RELEASE;ORAL; 15MEQ
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
POTASSIUM CITRATE	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	212779	ANI PHARMS
POTASSIUM CITRATE	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	214420	ASCENT PHARMS INC
POTASSIUM CITRATE	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	212799	BIONPHARMA
POTASSIUM CITRATE	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	214426	HIBROW HLTHCARE
POTASSIUM CITRATE	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	206813	STRIDES PHARMA
POTASSIUM CITRATE	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	209758	TEVA PHARMS USA INC
POTASSIUM CITRATE	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	203546	ZYDUS PHARMS
UROCIT-K	POTASSIUM CITRATE	15MEQ	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	019071	MISSION PHARMA

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