Orange Book product · Brand (NDA)
PRECEDEX
DEXMEDETOMIDINE HYDROCHLORIDE
At a glance
Jan 31, 2020
Approved
Brand (NDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 31, 2020
6 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
DEXMEDETOMIDINE HYDROCHLORIDE
Strength
EQ 1MG BASE/250ML (EQ 4MCG BASE/ML)
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
NDA 021038
Product number
005
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.
- 2022IGALMIBrand (NDA)
NDA 215390 · BIOXCEL
- 2015DEXMEDETOMIDINE HYDROCHLORIDEBrand (NDA)
NDA 206628 · HQ SPCLT PHARMA
- 2026DEXMEDETOMIDINE HYDROCHLORIDEGeneric (ANDA)
ANDA 208103 · BAXTER HLTHCARE CORP
- 2026DEXMEDETOMIDINE HYDROCHLORIDEGeneric (ANDA)
ANDA 218675 · KNACK
- 2026DEXMEDETOMIDINE HYDROCHLORIDEGeneric (ANDA)
ANDA 220315 · DR REDDYS
- 2025DEXMEDETOMIDINE HYDROCHLORIDEGeneric (ANDA)
ANDA 206407 · HIKMA
- 2024DEXMEDETOMIDINE HYDROCHLORIDEGeneric (ANDA)
ANDA 218112 · SOMERSET
- 2023DEXMEDETOMIDINE HYDROCHLORIDEGeneric (ANDA)
ANDA 217308 · MILLA PHARMS
- 2023DEXMEDETOMIDINE HYDROCHLORIDEGeneric (ANDA)
ANDA 216604 · AMNEAL
- 2021DEXMEDETOMIDINE HYDROCHLORIDEGeneric (ANDA)
ANDA 214794 · PIRAMAL CRITICAL
- 2020DEXMEDETOMIDINE HYDROCHLORIDEGeneric (ANDA)
ANDA 210321 · EUGIA PHARMA
- 2020DEXMEDETOMIDINE HYDROCHLORIDEGeneric (ANDA)
ANDA 212857 · TAGI
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.
