APPLICATION
NDA008693
TYPE
NDA
ORIGINAL APPROVAL
1953-02-06
LATEST ACTION
1998-02-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
FURADANTINDiscontinued
NITROFURANTOIN 100MG · TABLET · ORAL
FURADANTINDiscontinued
NITROFURANTOIN 50MG · TABLET · ORAL
Approval history
1998-02-17Labeling · Supplement 28 · priorityAP
1998-02-17Labeling · Supplement 26 · priorityAP
1997-07-16Labeling · Supplement 30 · priorityAP
1997-03-27Labeling · Supplement 29 · priorityAP
1993-08-09Manufacturing (CMC) · Supplement 27 · priorityAP
1993-05-18Efficacy · Supplement 20 · priorityAP
1983-07-14Manufacturing (CMC) · Supplement 21 · priorityAP
1982-11-18Labeling · Supplement 19 · priorityAP
1979-12-17Labeling · Supplement 16 · priorityAP
1979-06-29Manufacturing (CMC) · Supplement 17 · priorityAP
1979-03-16Manufacturing (CMC) · Supplement 15 · priorityAP
1976-06-30Manufacturing (CMC) · Supplement 10 · priorityAP
1976-05-11Manufacturing (CMC) · Supplement 11 · priorityAP
1953-02-06Type 1 - New Molecular Entity · 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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