FDA.reportPublic FDA data

Application 209307

Type
ANDA
Sponsor
GLAND 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
43598-975DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDEDr.Reddy's Laboratories IncANDACurrent
43598-975DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDEDr.Reddy's Laboratories IncANDACurrent
43598-976DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDEDr.Reddy's Laboratories IncANDACurrent
43598-976DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDEDr.Reddy's Laboratories IncANDACurrent
66794-234Dexmedetomidine HydrochlorideDexmedetomidine HydrochloridePiramal Critical Care IncANDACurrent
66794-234Dexmedetomidine HydrochlorideDexmedetomidine HydrochloridePiramal Critical Care IncANDACurrent
66794-234Dexmedetomidine HydrochlorideDexmedetomidine HydrochloridePiramal Critical Care IncANDACurrent
66794-234Dexmedetomidine HydrochlorideDexmedetomidine HydrochloridePiramal Critical Care IncANDACurrent
66794-234Dexmedetomidine HydrochlorideDexmedetomidine HydrochloridePiramal Critical Care IncANDACurrent
66794-235Dexmedetomidine HydrochlorideDexmedetomidine HydrochloridePiramal Critical Care IncANDACurrent
66794-235Dexmedetomidine HydrochlorideDexmedetomidine HydrochloridePiramal Critical Care IncANDACurrent
66794-235Dexmedetomidine HydrochlorideDexmedetomidine HydrochloridePiramal Critical Care IncANDACurrent
66794-235Dexmedetomidine HydrochlorideDexmedetomidine HydrochloridePiramal Critical Care IncANDACurrent
66794-235Dexmedetomidine HydrochlorideDexmedetomidine HydrochloridePiramal Critical Care IncANDACurrent
68083-238Dexmedetomidine HydrochlorideDexmedetomidine HydrochlorideGland Pharma LimitedANDACurrent
68083-239Dexmedetomidine HydrochlorideDexmedetomidine HydrochlorideGland Pharma LimitedANDACurrent