FDA.reportPublic FDA data

Application 204023

Type
ANDA
Sponsor
ACCORD HLTHCARE

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
16729-239Dexmedetomidine hydrochlorideDexmedetomidine hydrochlorideAccord Healthcare Inc.ANDACurrent
16729-239DexmedetomidineDexmedetomidineAccord Healthcare Inc.ANDACurrent
16729-432Dexmedetomidine hydrochlorideDexmedetomidine hydrochlorideAccord Healthcare Inc.ANDACurrent
16729-432DEXMEDETOMIDINEDEXMEDETOMIDINEAccord Healthcare Inc.ANDACurrent
16729-432DEXMEDETOMIDINEDEXMEDETOMIDINEAccord Healthcare Inc.ANDACurrent
71872-7030Dexmedetomidine hydrochlorideDexmedetomidine hydrochlorideMedical Purchasing Solutions, LLCANDACurrent