Details for New Drug Application (NDA): 019071

NDA 019071 describes UROCIT-K, which is a drug marketed by Mission Pharma and is included in one NDA. It is available from three suppliers. Additional details are available on the UROCIT-K profile page.

The generic ingredient in UROCIT-K is potassium citrate. There are two hundred and forty drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the potassium citrate profile page.

Summary for 019071

Tradename:	UROCIT-K
Applicant:	Mission Pharma
Ingredient:	potassium citrate
Patents:	0

Pharmacology for NDA: 019071

Mechanism of Action	Acidifying Activity Calcium Chelating Activity
Physiological Effect	Decreased Coagulation Factor Activity

Medical Subject Heading (MeSH) Categories for 019071

Diuretics

Expectorants

Suppliers and Packaging for NDA: 019071

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
UROCIT-K	potassium citrate	TABLET, EXTENDED RELEASE;ORAL	019071	NDA	Mission Pharmacal Company	0178-0600	0178-0600-01	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0178-0600-01)
UROCIT-K	potassium citrate	TABLET, EXTENDED RELEASE;ORAL	019071	NDA	Mission Pharmacal Company	0178-0610	0178-0610-01	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0178-0610-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	5MEQ
Approval Date:	Aug 30, 1985	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	10MEQ
Approval Date:	Aug 31, 1992	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	15MEQ
Approval Date:	Dec 30, 2009	TE:	AB	RLD:	Yes

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