APPLICATION
NDA017430
TYPE
NDA
ORIGINAL APPROVAL
1973-04-17
LATEST ACTION
2007-12-07
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Discontinued
Products
NEGGRAMDiscontinued
NALIDIXIC ACID 250MG/5ML · SUSPENSION · ORAL
Approval history
2007-12-07Labeling · Supplement 8AP
2007-12-07Labeling · Supplement 31 · standardAP
2007-12-07Labeling · Supplement 5AP
2007-12-07Labeling · Supplement 14AP
1995-02-07Labeling · Supplement 19AP
1994-10-31Manufacturing (CMC) · Supplement 25 · standardAP
1993-08-03Manufacturing (CMC) · Supplement 24 · standardAP
1991-06-24Manufacturing (CMC) · Supplement 23 · standardAP
1991-05-13Manufacturing (CMC) · Supplement 22 · standardAP
1990-07-30Manufacturing (CMC) · Supplement 21 · standardAP
1990-07-13Manufacturing (CMC) · Supplement 20 · standardAP
1988-03-14Manufacturing (CMC) · Supplement 18 · standardAP
1987-08-21Labeling · Supplement 16AP
1986-04-21Labeling · Supplement 17AP
1984-02-06Manufacturing (CMC) · Supplement 15 · standardAP
1983-06-02Manufacturing (CMC) · Supplement 13 · standardAP
1981-08-18Manufacturing (CMC) · Supplement 12 · standardAP
1981-02-23Labeling · Supplement 10AP
1980-06-30Labeling · Supplement 11AP
1977-07-01Manufacturing (CMC) · Supplement 9 · standardAP
1977-02-23Labeling · Supplement 7AP
1976-09-23Manufacturing (CMC) · Supplement 6 · standardAP
1976-04-08Manufacturing (CMC) · Supplement 4 · standardAP
1975-03-13Manufacturing (CMC) · Supplement 2 · standardAP
1975-02-28Manufacturing (CMC) · Supplement 3 · standardAP
1973-04-17Type 3 - New Dosage Form · Original · standardAP
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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