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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019071
Company: MISSION PHARMA

Products on NDA 019071

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019071

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/30/1985	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY; Orphan		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/10/2021	SUPPL-13	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019071s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/019071Orig1s013ltr.pdf
12/30/2009	SUPPL-12	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019071s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019071s012ltr.pdf
02/13/2002	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
12/26/2000	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
03/01/1999	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
08/31/1992	SUPPL-4	Manufacturing (CMC)-Formulation		Label is not available on this site.
10/30/1992	SUPPL-3	Labeling		Label is not available on this site.
08/31/1992	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
01/13/1986	SUPPL-1	Labeling		Label is not available on this site.

Labels for NDA 019071

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/10/2021	SUPPL-13	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019071s013lbl.pdf
12/10/2021	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019071s013lbl.pdf
12/30/2009	SUPPL-12	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019071s012lbl.pdf
12/30/2009	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019071s012lbl.pdf

Therapeutic Equivalents for NDA 019071

UROCIT-K

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	EYWA
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	EYWA
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	EYWA
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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