FDA.reportPublic FDA data

Application 212857

Type
ANDA
Sponsor
TAGI

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDEINJECTABLE;INJECTIONEQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)NoNo
002DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDEINJECTABLE;INJECTIONEQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)NoNo
003DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDEINJECTABLE;INJECTIONEQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51224-015Dexmedetomidine Hydrochloride in Sodium ChlorideDexmedetomidine HydrochlorideTAGI Pharma, Inc.ANDACurrent
51224-015Dexmedetomidine Hydrochloride in Sodium ChlorideDexmedetomidine HydrochlorideTAGI Pharma, Inc.ANDACurrent
51224-115Dexmedetomidine Hydrochloride in Sodium ChlorideDexmedetomidine HydrochlorideTAGI Pharma, Inc.ANDACurrent
51224-115Dexmedetomidine Hydrochloride in Sodium ChlorideDexmedetomidine HydrochlorideTAGI Pharma, Inc.ANDACurrent
51224-215Dexmedetomidine Hydrochloride in Sodium ChlorideDexmedetomidine HydrochlorideTAGI Pharma, Inc.ANDACurrent
51224-215Dexmedetomidine Hydrochloride in Sodium ChlorideDexmedetomidine HydrochlorideTAGI Pharma, Inc.ANDACurrent
68094-047Dexmedetomidine Hydrochloride in Sodium ChlorideDexmedetomidine HydrochloridePrecision Dose, Inc.ANDACurrent
68094-047Dexmedetomidine Hydrochloride in Sodium ChlorideDexmedetomidine HydrochloridePrecision Dose, Inc.ANDACurrent
68094-047Dexmedetomidine Hydrochloride in Sodium ChlorideDexmedetomidine HydrochloridePrecision Dose, Inc.ANDACurrent
68094-147Dexmedetomidine Hydrochloride in Sodium ChlorideDexmedetomidine HydrochloridePrecision Dose, Inc.ANDACurrent
68094-147Dexmedetomidine Hydrochloride in Sodium ChlorideDexmedetomidine HydrochloridePrecision Dose, Inc.ANDACurrent
68094-147Dexmedetomidine Hydrochloride in Sodium ChlorideDexmedetomidine HydrochloridePrecision Dose, Inc.ANDACurrent
68094-247Dexmedetomidine Hydrochloride in Sodium ChlorideDexmedetomidine HydrochloridePrecision Dose, Inc.ANDACurrent
68094-247Dexmedetomidine Hydrochloride in Sodium ChlorideDexmedetomidine HydrochloridePrecision Dose, Inc.ANDACurrent
68094-247Dexmedetomidine Hydrochloride in Sodium ChlorideDexmedetomidine HydrochloridePrecision Dose, Inc.ANDACurrent