Orange Book product · Generic (ANDA)
SODIUM OXYBATE
SODIUM OXYBATE
Generic (ANDA)ANDA 203631TE AARX AMNEAL
At a glance
Sep 10, 2025
Approved
Generic (ANDA)
Application
AA
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 10, 2025
9 mo ago
Today
Pharmaceutical detail
Active ingredient
SODIUM OXYBATE
Strength
0.5GM/ML
Dosage form
SOLUTION
Route
ORAL
TE code
AA
Application
ANDA 203631
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of SODIUM OXYBATE
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.
