Orange Book product · Generic (ANDA)
DEXMEDETOMIDINE HYDROCHLORIDE
DEXMEDETOMIDINE HYDROCHLORIDE
At a glance
Oct 17, 2016
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 17, 2016
9 yr 10 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
ANDA 204686
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
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NDA 206628 · HQ SPCLT PHARMA
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ANDA 208103 · BAXTER HLTHCARE CORP
- 2026DEXMEDETOMIDINE HYDROCHLORIDEGeneric (ANDA)
ANDA 218675 · KNACK
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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
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.
