Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 019071

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UROCIT-K (POTASSIUM CITRATE)
5MEQ
Marketing Status: Prescription

Active Ingredient: POTASSIUM CITRATE
Proprietary Name: UROCIT-K
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 5MEQ
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N019071
Product Number: 001
Approval Date: Aug 30, 1985
Applicant Holder Full Name: MISSION PHARMACAL CO
Marketing Status:  Prescription
Patent and Exclusivity Information

UROCIT-K (POTASSIUM CITRATE)
10MEQ
Marketing Status: Prescription

Active Ingredient: POTASSIUM CITRATE
Proprietary Name: UROCIT-K
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 10MEQ
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N019071
Product Number: 002
Approval Date: Aug 31, 1992
Applicant Holder Full Name: MISSION PHARMACAL CO
Marketing Status:  Prescription
Patent and Exclusivity Information

UROCIT-K (POTASSIUM CITRATE)
15MEQ
Marketing Status: Prescription

Active Ingredient: POTASSIUM CITRATE
Proprietary Name: UROCIT-K
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 15MEQ
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N019071
Product Number: 003
Approval Date: Dec 30, 2009
Applicant Holder Full Name: MISSION PHARMACAL CO
Marketing Status:  Prescription
Patent and Exclusivity Information