Orange Book product · Generic (ANDA)
EPHEDRINE SULFATE
EPHEDRINE SULFATE
At a glance
Apr 14, 2022
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 14, 2022
4 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
EPHEDRINE SULFATE
Strength
50MG/ML (50MG/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
AP
Application
ANDA 216129
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of EPHEDRINE SULFATE
- 2023EMERPHEDBrand (NDA)
NDA 213407 · NEXUS
- 2022EPHEDRINE SULFATEBrand (NDA)
NDA 213994 · PH HEALTH
- 2021AKOVAZBrand (NDA)
NDA 208289 · EXELA PHARMA
- 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
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.
