FDA.reportPublic FDA data

Application 203972

Type
ANDA
Sponsor
PAR STERILE PRODUCTS

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
42023-146Dexmedetomidine HydrochlorideDexmedetomidine HydrochloridePar Pharmaceutical, Inc.ANDACurrent
42023-146Dexmedetomidine HydrochlorideDexmedetomidine HydrochloridePar Pharmaceutical, Inc.ANDACurrent
42023-146Dexmedetomidine HydrochlorideDexmedetomidine HydrochloridePar Pharmaceutical, Inc.ANDACurrent
42023-146Dexmedetomidine HydrochlorideDexmedetomidine HydrochloridePar Pharmaceutical, Inc.ANDACurrent
42023-146Dexmedetomidine HydrochlorideDexmedetomidine HydrochloridePar Pharmaceutical, Inc.ANDACurrent