Orange Book product · Brand (NDA)
AKOVAZ
EPHEDRINE SULFATE
At a glance
Aug 02, 2021
Approved
Brand (NDA)
Application
AP3
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 02, 2021
4 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
EPHEDRINE SULFATE
Strength
25MG/5ML (5MG/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
AP3
Application
NDA 208289
Product number
002
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.
- 2023EMERPHEDBrand (NDA)
NDA 213407 · NEXUS
- 2022EPHEDRINE SULFATEBrand (NDA)
NDA 213994 · PH HEALTH
- 2017EPHEDRINE SULFATEBrand (NDA)
NDA 208609 · RENEW PHARMS
- 2017CORPHEDRABrand (NDA)
NDA 208943 · PH HEALTH
- 2026EPHEDRINE SULFATEGeneric (ANDA)
ANDA 219991 · FRESENIUS KABI USA
- 2025EPHEDRINE SULFATEGeneric (ANDA)
ANDA 215593 · CIVICA
- 2025EPHEDRINE SULFATEGeneric (ANDA)
ANDA 218271 · FRESENIUS KABI USA
- 2025EPHEDRINE SULFATEGeneric (ANDA)
ANDA 218211 · GLAND
- 2024EPHEDRINE SULFATEGeneric (ANDA)
ANDA 217721 · HIKMA
- 2024EPHEDRINE SULFATEGeneric (ANDA)
ANDA 219050 · CAPLIN
- 2023EPHEDRINE SULFATEGeneric (ANDA)
ANDA 217276 · ZYDUS PHARMS
- 2023EPHEDRINE SULFATEGeneric (ANDA)
ANDA 214528 · SAGENT PHARMS INC
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.
