FDA Orange Book · active-ingredient family
Loxapine succinate
Loxapine succinate is approved as 1 brand and 7 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:LOXITANE · NDA 017525
1
Brand (NDA)
7
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LOXITANERLD×7 | TEVA BRANDED PHARM | NDA 017525 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (7)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LOXAPINE SUCCINATE×4 | LANNETT CO INC | ANDA 090695 | AB | Sep 26, 2011 | |
| LOXAPINE SUCCINATE×4 | ELITE LABS INC | ANDA 076868 | AB | Aug 04, 2005 | |
| LOXAPINE SUCCINATE×4 | RISING | ANDA 076762 | — | Nov 01, 2004 | |
| LOXAPINE SUCCINATE | WATSON LABS | ANDA 072204 | AB | Jun 15, 1988 | |
| LOXAPINE SUCCINATE | WATSON LABS | ANDA 072205 | AB | Jun 15, 1988 | |
| LOXAPINE SUCCINATE | WATSON LABS | ANDA 072206 | AB | Jun 15, 1988 | |
| LOXAPINE SUCCINATE | WATSON LABS | ANDA 072062 | AB | Jun 15, 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.
Loxapine succinate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
