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Details for New Drug Application (NDA): 019071

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NDA 019071 describes UROCIT-K, which is a drug marketed by Mission Pharma and is included in one NDA. It is available from four 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 twenty-five drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the potassium citrate profile page.

Summary for NDA: 019071

Tradename:
UROCIT-K
Applicant:
Mission Pharma
Ingredient:
potassium citrate
Patents:0
Therapeutic Class:Therapeutic Nutrients/Minerals/Electrolytes
Formulation / Manufacturing:see details

Pharmacology for NDA: 019071

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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength5MEQ
Approval Date:Aug 30, 1985TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength10MEQ
Approval Date:Aug 31, 1992TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength15MEQ
Approval Date:Dec 30, 2009TE:ABRLD:Yes


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