FDA.reportPublic FDA data

Application 209065

Type
ANDA
Sponsor
JIANGSU HENGRUI MED

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEXMEDETOMIDINEDEXMEDETOMIDINE HYDROCHLORIDEINJECTABLE;INJECTIONEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)NoNo
002DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDEINJECTABLE;INJECTIONEQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)NoNo
003DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDEINJECTABLE;INJECTIONEQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)NoNo
004DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDEINJECTABLE;INJECTIONEQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0781-3493DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDEDEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDESandoz Inc.ANDACurrent
0781-3493DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDEDEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDESandoz Inc.ANDACurrent
0781-3493DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDEDEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDESandoz Inc.ANDACurrent
0781-3493DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDEDEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDESandoz Inc.ANDACurrent
0781-3493DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDEDEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDESandoz Inc.ANDACurrent
0781-3494DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDEDEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDESandoz Inc.ANDACurrent
0781-3494DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDEDEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDESandoz Inc.ANDACurrent
0781-3494DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDEDEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDESandoz Inc.ANDACurrent
0781-3494DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDEDEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDESandoz Inc.ANDACurrent
0781-3494DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDEDEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDESandoz Inc.ANDACurrent
0781-3495DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDEDEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDESandoz Inc.ANDACurrent
0781-3495DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDEDEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDESandoz Inc.ANDACurrent
0781-3495DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDEDEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDESandoz Inc.ANDACurrent
0781-3495DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDEDEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDESandoz Inc.ANDACurrent
0781-3495DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDEDEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDESandoz Inc.ANDACurrent
57884-3091DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDEJiangsu Hengrui Medicine Co., Ltd.ANDACurrent
57884-3091DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDEJiangsu Hengrui Medicine Co., Ltd.ANDACurrent
57884-3091DEXMEDETOMIDINEDEXMEDETOMIDINEJiangsu Hengrui Medicine Co., Ltd.ANDACurrent
57884-3091DEXMEDETOMIDINEDEXMEDETOMIDINEJiangsu Hengrui Medicine Co., Ltd.ANDACurrent
57884-3091DEXMEDETOMIDINEDEXMEDETOMIDINEJiangsu Hengrui Medicine Co., Ltd.ANDACurrent
70860-605DexmedetomidinedexmedetomidineAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-605DexmedetomidinedexmedetomidineAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-605DexmedetomidinedexmedetomidineAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-605DexmedetomidinedexmedetomidineAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-605DexmedetomidinedexmedetomidineAthenex Pharmaceutical Division, LLC.ANDACurrent
71872-7150DexmedetomidinedexmedetomidineMedical Purchasing Solutions, LLC.ANDACurrent