FDA.reportPublic FDA data

Application 205046

Type
ANDA
Sponsor
WEST-WARD PHARMS INT

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
0143-9532Dexmedetomidine HClDexmedetomidine HClWest-Ward Pharmaceuticals CorpANDACurrent
0143-9532Dexmedetomidine HClDexmedetomidine HClHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9532Dexmedetomidine HClDexmedetomidine HClHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9532Dexmedetomidine HClDexmedetomidine HClHikma Pharmaceuticals USA Inc.ANDACurrent
71872-7218Dexmedetomidine HClDexmedetomidine HClMedical Purchasing Solutions, LLCANDACurrent