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Johnson and Johnson
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Generated: June 18, 2018

DrugPatentWatch Database Preview

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 five 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 thirty-five drug master file entries for this compound. Ten 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
Therapeutic Class:Therapeutic Nutrients/Minerals/Electrolytes
Formulation / Manufacturing:see details
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 N 0178-0600-01
UROCIT-K potassium citrate TABLET, EXTENDED RELEASE;ORAL 019071 NDA Mission Pharmacal Company 0178-0610 N 0178-0610-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength5MEQ
Approval Date:Aug 30, 1985TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength10MEQ
Approval Date:Aug 31, 1992TE:ABRLD:Yes

Profile for product number 003

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

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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Moodys
Dow
US Army
Teva
Queensland Health
Boehringer Ingelheim
Colorcon
Johnson and Johnson

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