FDA Orange Book · active-ingredient family
Nalidixic acid
Nalidixic acid is approved as 2 brand and 6 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:NEGGRAM · NDA 017430
2
Brand (NDA)
6
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · suspension, tablet
Generic (ANDA) products (6)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NALIDIXIC ACID | SUN PHARM INDUSTRIES | ANDA 070272 | — | Jun 29, 1988 | |
| NALIDIXIC ACID | SUN PHARM INDUSTRIES | ANDA 070270 | — | Jun 29, 1988 | |
| NALIDIXIC ACID | SUN PHARM INDUSTRIES | ANDA 070271 | — | Jun 29, 1988 | |
| NALIDIXIC ACID | WATSON LABS | ANDA 071919 | — | Jun 29, 1988 | |
| NALIDIXIC ACID | WATSON LABS | ANDA 071936 | — | Jun 29, 1988 | |
| NALIDIXIC ACID | WATSON LABS | ANDA 072061 | — | Jun 29, 1988 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Nalidixic acid — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
