FDA.reportPublic FDA data

Application 212791

Type
ANDA
Sponsor
SLAYBACK PHARMA LLC

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
003DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDEINJECTABLE;INJECTIONEQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
71225-126DEXMEDETOMIDINE HYDROCHLORIDEdexmedetomidine hydrochlorideSlayback Pharma LLCANDACurrent
71225-126DEXMEDETOMIDINE HYDROCHLORIDEdexmedetomidine hydrochlorideSlayback Pharma LLCANDACurrent
71225-126DEXMEDETOMIDINE HYDROCHLORIDEdexmedetomidine hydrochlorideSlayback Pharma LLCANDACurrent
71225-126DEXMEDETOMIDINE HYDROCHLORIDEdexmedetomidine hydrochlorideSlayback Pharma LLCANDACurrent
71225-132DEXMEDETOMIDINE HYDROCHLORIDEdexmedetomidine hydrochlorideSlayback Pharma LLCANDACurrent
71225-132DEXMEDETOMIDINE HYDROCHLORIDEdexmedetomidine hydrochlorideSlayback Pharma LLCANDACurrent
71225-132DEXMEDETOMIDINE HYDROCHLORIDEdexmedetomidine hydrochlorideSlayback Pharma LLCANDACurrent
71225-133DEXMEDETOMIDINE HYDROCHLORIDEdexmedetomidine hydrochlorideSlayback Pharma LLCANDACurrent
71225-133DEXMEDETOMIDINE HYDROCHLORIDEdexmedetomidine hydrochlorideSlayback Pharma LLCANDACurrent
71225-133DEXMEDETOMIDINE HYDROCHLORIDEdexmedetomidine hydrochlorideSlayback Pharma LLCANDACurrent
72572-127DEXMEDETOMIDINE HYDROCHLORIDEdexmedetomidine hydrochlorideCIVICA, INC.ANDACurrent
72572-128DEXMEDETOMIDINE HYDROCHLORIDEdexmedetomidine hydrochlorideCIVICA, INC.ANDACurrent