Orange Book product · Brand (NDA)
PRECEDEX
DEXMEDETOMIDINE HYDROCHLORIDE
At a glance
Dec 17, 1999
Approved
Brand (NDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 17, 1999
26 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
DEXMEDETOMIDINE HYDROCHLORIDE
Strength
EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
NDA 021038
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.
- 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.
