FDA Drug NDCs and Drug Labels for dexmedetomidine

Manufacturer Route Drug Strength NDCs Type Application Holder Approval Date PI / Labels / Letters
Hikma Pharmaceu intravenous dexmedetomidine hydrochloride 4 ug/mL 0143-9525-10 ANDA HIKMA 2020-01-30
WG Critical Car intravenous dexmedetomidine hydrochloride 100 ug/mL 44567-601-04 NDA HQ SPCLT PHARMA 2018-06-22
TAGI Pharma, In intravenous dexmedetomidine hydrochloride 4 ug/mL 51224-215-10 ANDA TAGI 2020-11-23
AuroMedics Phar intravenous dexmedetomidine hydrochloride in 0.9% sodium chloride 4 ug/mL 55150-297-10 ANDA EUGIA PHARMA 2016-03-17
Filing Details
NDA Filings
WG Critic , Hospira, , General I , BioXcel T , Henry Sch
ANDAs (Approved New Drug Applications)
Hikma Pha , TAGI Phar , AuroMedic , Sun Pharm , Gland Pha , Precision , Par Pharm , Baxter He , Piramal C , Amneal Ph , CIVICA, I , Akorn , Dr.Reddy' , Mylan Ins , Medical P , Accord He , Fresenius , Slayback , Sandoz In , Zydus Pha , Athenex P , Meitheal , Cadila He , ACTAVIS I , TEVA PHAR
Private Labels

NovaPlus
Baxter Healthcare Corporation - DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE - INTRAVENOUS - 43066-557-12 - 400 ug/100mL

Civica
SLAYBACK PHARMA LLC - DEXMEDETOMIDINE HYDROCHLORIDE - INTRAVENOUS - 72572-127-10 - 4 ug/mL

Civica
SLAYBACK PHARMA LLC - DEXMEDETOMIDINE HYDROCHLORIDE - INTRAVENOUS - 72572-128-08 - 4 ug/mL

Schein
HOSPIRA - DEXMEDETOMIDINE HYDROCHLORIDE - INTRAVENOUS - 52584-638-02 - 100 ug/mL