Orange Book product · Generic (ANDA)
DEXMEDETOMIDINE HYDROCHLORIDE
DEXMEDETOMIDINE HYDROCHLORIDE
At a glance
May 15, 2023
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 15, 2023
3 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
DEXMEDETOMIDINE HYDROCHLORIDE
Strength
EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
ANDA 216604
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of DEXMEDETOMIDINE HYDROCHLORIDE
- 2022IGALMIBrand (NDA)
NDA 215390 · BIOXCEL
- 2020PRECEDEXBrand (NDA)
NDA 021038 · HOSPIRA
- 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
- 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.
