Sold as Neggram. Every FDA application for this active ingredient: 2 branded and 6 generic.
As of Nov 13, 2026, FDA lists 8 applications for Nalidixic Acid (sold as Neggram), first approved Mar 6, 1964, with 0 new uses approved and 0 published complete response letters.
| Mar 6, 1964 | NeggramNDA 14214 · New molecular entity | Sanofi Aventis US | 36 | Discontinued |
| Apr 17, 1973 | NeggramNDA 17430 · New dosage form | Sanofi Aventis US | 31 | Discontinued |
| Mar 28, 1986 | Nalidixic AcidANDA 70270 | Sun Pharm Industries | 6 | Discontinued |
| Mar 28, 1986 | Nalidixic AcidANDA 70272 | Sun Pharm Industries | 6 | Discontinued |
| Mar 29, 1986 | Nalidixic AcidANDA 70271 | Sun Pharm Industries | 6 | Discontinued |
| Jun 28, 1988 | Nalidixic AcidANDA 71919 | Watson Labs | 5 | Discontinued |
| Jun 28, 1988 | Nalidixic AcidANDA 71936 | Watson Labs | 5 | Discontinued |
| Jun 28, 1988 | Nalidixic AcidANDA 72061 | Watson Labs | 5 | Discontinued |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
Sanofi Aventis US
Sun Pharm Industries