← FDA DRUG APPROVALS

FDA NDA · NDA019481

RENACIDIN

citric acid, gluconolactone and magnesium carbonate

Sponsor: UNITED GUARDIAN

APPLICATION
NDA019481
TYPE
NDA
ORIGINAL APPROVAL
1990-10-02
LATEST ACTION
2015-12-16
ROUTE
IRRIGATION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

RENACIDIN · ReferencePrescription
CITRIC ACID 6.602GM/100ML, GLUCONOLACTONE 198MG/100ML, MAGNESIUM CARBONATE 3.177GM/100ML · SOLUTION · IRRIGATION

Approval history

2015-12-16Manufacturing (CMC) · Supplement 12 · priorityAP
2015-10-30Labeling · Supplement 13 · standard — Letter ↗AP
2014-02-12Manufacturing (CMC) · Supplement 11 · priorityAP
2007-05-03Manufacturing (CMC) · Supplement 7 — Letter ↗AP
1998-09-30Manufacturing (CMC) · Supplement 6 · priorityAP
1998-08-31Manufacturing (CMC) · Supplement 5 · priorityAP
1996-10-28Manufacturing (CMC) · Supplement 4 · priorityAP
1993-12-03Manufacturing (CMC) · Supplement 3 · priorityAP
1993-04-16Manufacturing (CMC) · Supplement 1 · priorityAP
1993-04-13Manufacturing (CMC) · Supplement 2 · priorityAP
1990-10-02Type 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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