FDA.reportPublic FDA data

Application 205867

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDEINJECTABLE;INJECTIONEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55150-209DexmedetomidineDexmedetomidineAuroMedics Pharma LLCANDACurrent
55150-209DexmedetomidineDexmedetomidineAuroMedics Pharma LLCANDACurrent
55150-209DexmedetomidineDexmedetomidineAuroMedics Pharma LLCANDACurrent
55150-209Dexmedetomidine HydrochlorideDexmedetomidine HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-209DexmedetomidineDexmedetomidineAuroMedics Pharma LLCANDACurrent
55150-209DexmedetomidineDexmedetomidineEugia US LLCANDACurrent
55150-209Dexmedetomidine HydrochlorideDexmedetomidine HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-209Dexmedetomidine HydrochlorideDexmedetomidine HydrochlorideAuroMedics Pharma LLCANDACurrent
71872-7031Dexmedetomidine HydrochlorideDexmedetomidine HydrochlorideMedical Purchasing Solutions, LLCANDACurrent