Orange Book product · Generic (ANDA)
OXAZEPAM
OXAZEPAM
At a glance
Mar 03, 2025
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 03, 2025
1 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
OXAZEPAM
Strength
10MG
Dosage form
CAPSULE
Route
ORAL
TE code
AB
Application
ANDA 218261
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of OXAZEPAM
- —SERAXBrand (NDA)
NDA 015539 · ALPHARMA US PHARMS
- 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.
