APPLICATION
NDA007529
TYPE
NDA
ORIGINAL APPROVAL
1950-07-12
LATEST ACTION
2016-03-09
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
QUINIDINE GLUCONATE · ReferenceDiscontinued
QUINIDINE GLUCONATE 80MG/ML · INJECTABLE · INJECTION
Approval history
2016-03-09Manufacturing (CMC) · Supplement 45 · priorityAP
2014-08-11Manufacturing (CMC) · Supplement 43 · priorityAP
1999-06-09Labeling · Supplement 17 · standardAP
1998-06-15Labeling · Supplement 16 · standardAP
1996-03-29Manufacturing (CMC) · Supplement 15 · priorityAP
1995-07-20Labeling · Supplement 14 · standardAP
1994-03-07Labeling · Supplement 13 · standardAP
1993-12-06Manufacturing (CMC) · Supplement 12 · priorityAP
1992-12-17Labeling · Supplement 11 · standardAP
1991-06-12Efficacy · Supplement 10AP
1989-07-10Labeling · Supplement 9AP
1989-02-10Labeling · Supplement 7AP
1989-02-10Labeling · Supplement 5AP
1950-07-12Type 2 - New Active Ingredient · Original · priorityAP
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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