APPLICATION
NDA018040
TYPE
NDA
ORIGINAL APPROVAL
1978-10-04
LATEST ACTION
1997-06-25
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
MONISTATDiscontinued
MICONAZOLE 10MG/ML · INJECTABLE · INJECTION
Approval history
1997-06-25Labeling · Supplement 4AP
1993-07-08Labeling · Supplement 13AP
1990-03-09Labeling · Supplement 9AP
1982-04-20Labeling · Supplement 5AP
1979-03-08Labeling · Supplement 2AP
1978-11-20Labeling · Supplement 1AP
1978-10-04Type 3 - New Dosage Form · 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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