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FDA NDA · NDA010744

DARBID

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APPLICATION
NDA010744
TYPE
NDA
ORIGINAL APPROVAL
1957-10-09
LATEST ACTION
2007-12-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

DARBIDDiscontinued
ISOPROPAMIDE IODIDE EQ 5MG BASE · TABLET · ORAL

Approval history

2007-12-07Labeling · Supplement 12AP
2007-12-07Labeling · Supplement 10AP
2007-12-07Labeling · Supplement 19AP
2007-12-07Labeling · Supplement 15AP
2007-12-07Labeling · Supplement 13AP
2007-12-07Labeling · Supplement 11AP
2007-12-07Labeling · Supplement 16AP
1988-09-09Labeling · Supplement 21AP
1988-03-02Labeling · Supplement 18AP
1986-05-15Labeling · Supplement 20AP
1986-05-15Manufacturing (CMC) · Supplement 17 · standardAP
1957-10-09Type 3 - New Dosage Form · Original · standardAP
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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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