Orange Book product · Brand (NDA)
SERAX
OXAZEPAM
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
OXAZEPAM
Strength
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 015539
Product number
002
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.
- 2025OXAZEPAMGeneric (ANDA)
ANDA 218261 · LEADING
- 1990OXAZEPAMGeneric (ANDA)
ANDA 072953 · WATSON LABS
- 1990OXAZEPAMGeneric (ANDA)
ANDA 072954 · WATSON LABS
- 1990OXAZEPAMGeneric (ANDA)
ANDA 072952 · WATSON LABS TEVA
- 1988OXAZEPAMGeneric (ANDA)
ANDA 071756 · EPIC PHARMA LLC
- 1988OXAZEPAMGeneric (ANDA)
ANDA 072253 · ACTAVIS ELIZABETH
- 1988OXAZEPAMGeneric (ANDA)
ANDA 071955 · AM THERAP
- 1988OXAZEPAMGeneric (ANDA)
ANDA 071956 · AM THERAP
- 1988OXAZEPAMGeneric (ANDA)
ANDA 071957 · AM THERAP
- 1988ZAXOPAMGeneric (ANDA)
ANDA 070650 · QUANTUM PHARMICS
- 1988ZAXOPAMGeneric (ANDA)
ANDA 070640 · QUANTUM PHARMICS
- 1988ZAXOPAMGeneric (ANDA)
ANDA 070641 · QUANTUM PHARMICS
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.
