FDA.reportPublic FDA data

Application 210321

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDEINJECTABLE;INJECTIONEQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)NoNo
002DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDEINJECTABLE;INJECTIONEQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55150-296Dexmedetomidine HydrochlorideDexmedetomidine HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-296Dexmedetomidine HydrochlorideDexmedetomidine HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-296Dexmedetomidine HydrochlorideDexmedetomidine Hydrochloride in 0.9% Sodium ChlorideAuroMedics Pharma LLCANDACurrent
55150-296Dexmedetomidine HydrochlorideDexmedetomidine Hydrochloride in 0.9% Sodium ChlorideAuroMedics Pharma LLCANDACurrent
55150-296Dexmedetomidine HydrochlorideDexmedetomidine Hydrochloride in 0.9% Sodium ChlorideEugia US LLCANDACurrent
55150-297Dexmedetomidine HydrochlorideDexmedetomidine HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-297Dexmedetomidine HydrochlorideDexmedetomidine HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-297Dexmedetomidine HydrochlorideDexmedetomidine Hydrochloride in 0.9% Sodium ChlorideAuroMedics Pharma LLCANDACurrent
55150-297Dexmedetomidine HydrochlorideDexmedetomidine Hydrochloride in 0.9% Sodium ChlorideAuroMedics Pharma LLCANDACurrent
55150-297Dexmedetomidine HydrochlorideDexmedetomidine Hydrochloride in 0.9% Sodium ChlorideEugia US LLCANDACurrent