Orange Book product · Brand (NDA)
SODIUM ACETATE
SODIUM ACETATE
At a glance
May 04, 1983
Approved
Brand (NDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 04, 1983
43 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
SODIUM ACETATE
Strength
40MEQ/20ML (2MEQ/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
AP
Application
NDA 018893
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
- 2026SODIUM ACETATEGeneric (ANDA)
ANDA 220274 · EXTROVIS
- 2026SODIUM ACETATEGeneric (ANDA)
ANDA 218469 · AMNEAL
- 2025SODIUM ACETATEGeneric (ANDA)
ANDA 219826 · SOMERSET THERAPS LLC
- 2024SODIUM ACETATEGeneric (ANDA)
ANDA 216920 · HIKMA
- 2024SODIUM ACETATEGeneric (ANDA)
ANDA 214805 · MILLA PHARMS
- 2017SODIUM ACETATEGeneric (ANDA)
ANDA 206687 · FRESENIUS KABI USA
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.
