Orange Book product · Brand (NDA)
LOXITANE
LOXAPINE SUCCINATE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
LOXAPINE SUCCINATE
Strength
EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 017525
Product number
003
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2011LOXAPINE SUCCINATEGeneric (ANDA)
ANDA 090695 · LANNETT CO INC
- 2005LOXAPINE SUCCINATEGeneric (ANDA)
ANDA 076868 · ELITE LABS INC
- 2004LOXAPINE SUCCINATEGeneric (ANDA)
ANDA 076762 · RISING
- 1988LOXAPINE SUCCINATEGeneric (ANDA)
ANDA 072204 · WATSON LABS
- 1988LOXAPINE SUCCINATEGeneric (ANDA)
ANDA 072205 · WATSON LABS
- 1988LOXAPINE SUCCINATEGeneric (ANDA)
ANDA 072206 · WATSON LABS
- 1988LOXAPINE SUCCINATEGeneric (ANDA)
ANDA 072062 · WATSON LABS
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.
