← FDA DRUG APPROVALS

FDA NDA · NDA019071

POTASSIUM CITRATE

Sponsor: MISSION PHARMA

APPLICATION
NDA019071
TYPE
NDA
ORIGINAL APPROVAL
1985-08-30
LATEST ACTION
2021-12-10
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

UROCIT-K · ReferencePrescription
POTASSIUM CITRATE 10MEQ · TABLET, EXTENDED RELEASE · ORAL
UROCIT-K · ReferencePrescription
POTASSIUM CITRATE 15MEQ · TABLET, EXTENDED RELEASE · ORAL
UROCIT-K · ReferencePrescription
POTASSIUM CITRATE 5MEQ · TABLET, EXTENDED RELEASE · ORAL

Approval history

2021-12-10Labeling · Supplement 13 · standard — Letter ↗AP
2009-12-30Manufacturing (CMC) · Supplement 12 — Label ↗AP
2002-02-13Manufacturing (CMC) · Supplement 8 · priorityAP
2000-12-26Manufacturing (CMC) · Supplement 6 · priorityAP
1999-03-01Manufacturing (CMC) · Supplement 5 · priorityAP
1992-10-30Labeling · Supplement 3AP
1992-08-31Manufacturing (CMC) · Supplement 4 · priorityAP
1992-08-31Manufacturing (CMC) · Supplement 2 · priorityAP
1986-01-13Labeling · Supplement 1AP
1985-08-30Type 3 - New Dosage Form · Original · priorityAP
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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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