Orange Book product · Generic (ANDA)
EPHEDRINE SULFATE
EPHEDRINE SULFATE
At a glance
Mar 11, 2025
Approved
Generic (ANDA)
Application
AP2
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 11, 2025
1 yr 4 mo ago
Exclusivity ends · PC
Patent-challenge (180-day generic) exclusivity
Feb 21, 2026
4 mo ago
Today
Pharmaceutical detail
Active ingredient
EPHEDRINE SULFATE
Strength
25MG/5ML (5MG/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
AP2
Application
ANDA 218271
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 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
Marketing exclusivity (1)
- PCPatent-challenge (180-day generic) exclusivity
Feb 21, 2026
4 mo ago
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.
