FDA.reportPublic FDA data

Application 202126

Type
ANDA
Sponsor
SUN PHARM INDS INC

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
57664-596Dexmedetomidine HydrochlorideDEXMEDETOMIDINE HYDROCHLORIDESun Pharmaceuticals Industries, Inc.ANDACurrent
66794-230DexmedetomidineDexmedetomidinePiramal Critical Care IncANDACurrent
66794-230DexmedetomidineDexmedetomidinePiramal Critical Care IncANDACurrent
66794-230DexmedetomidineDexmedetomidinePiramal Critical Care IncANDACurrent
66794-233DexmedetomidineDexmedetomidinePiramal Critical Care IncANDACurrent
66794-233DexmedetomidineDexmedetomidinePiramal Critical Care IncANDACurrent
66794-233DexmedetomidineDexmedetomidinePiramal Critical Care IncANDACurrent
66794-233DexmedetomidineDexmedetomidinePiramal Critical Care IncANDACurrent
71872-7122Dexmedetomidine HydrochlorideDEXMEDETOMIDINE HYDROCHLORIDEMedical Purchasing Solutions, LLCANDACurrent
71872-7122Dexmedetomidine HydrochlorideDEXMEDETOMIDINE HYDROCHLORIDEMedical Purchasing Solutions, LLCANDACurrent