APPLICATION
ANDA071919
TYPE
ANDA
ORIGINAL APPROVAL
1988-06-28
LATEST ACTION
1996-05-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
NALIDIXIC ACIDDiscontinued
NALIDIXIC ACID 1GM · TABLET · ORAL
Approval history
1996-05-20Labeling · Supplement 6AP
1991-07-31Manufacturing (CMC) · Supplement 3AP
1991-07-31Manufacturing (CMC) · Supplement 2AP
1991-01-28Manufacturing (CMC) · Supplement 5AP
1990-06-29Manufacturing (CMC) · Supplement 1AP
1988-06-28OriginalAP
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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