FDA.reportPublic FDA data

Application 208532

Type
ANDA
Sponsor
BAXTER HLTHCARE CORP

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0338-9555DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDEBaxter Healthcare CompanyANDACurrent
0338-9555DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDEBaxter Healthcare CompanyANDACurrent
0338-9555DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDEBaxter Healthcare CompanyANDACurrent
0338-9555DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDEBaxter Healthcare CompanyANDACurrent
0338-9555DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDEBaxter Healthcare CompanyANDACurrent
0338-9555DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDEBaxter Healthcare CompanyANDACurrent
0338-9557DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDEBaxter Healthcare CompanyANDACurrent
0338-9557DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDEBaxter Healthcare CompanyANDACurrent
0338-9557DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDEBaxter Healthcare CompanyANDACurrent
0338-9557DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDEBaxter Healthcare CompanyANDACurrent
0338-9557DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDEBaxter Healthcare CompanyANDACurrent
0338-9557DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDEBaxter Healthcare CompanyANDACurrent
43066-555DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDEDEXMEDETOMIDINE HYDROCHLORIDE in 0.9% sodium chlorideBaxter Healthcare CorporationANDACurrent
43066-555DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDEDEXMEDETOMIDINE HYDROCHLORIDE in 0.9% sodium chlorideBaxter Healthcare CorporationANDACurrent
43066-555DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDEDEXMEDETOMIDINE HYDROCHLORIDE in 0.9% sodium chlorideBaxter Healthcare CorporationANDACurrent
43066-555DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDEDEXMEDETOMIDINE HYDROCHLORIDE in 0.9% sodium chlorideBaxter Healthcare CorporationANDACurrent
43066-555DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDEDEXMEDETOMIDINE HYDROCHLORIDE in 0.9% sodium chlorideBaxter Healthcare CorporationANDACurrent
43066-557DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDEDEXMEDETOMIDINE HYDROCHLORIDE in 0.9% sodium chlorideBaxter Healthcare CorporationANDACurrent
43066-557DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDEDEXMEDETOMIDINE HYDROCHLORIDE in 0.9% sodium chlorideBaxter Healthcare CorporationANDACurrent
43066-557DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDEDEXMEDETOMIDINE HYDROCHLORIDE in 0.9% sodium chlorideBaxter Healthcare CorporationANDACurrent
43066-557DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDEDEXMEDETOMIDINE HYDROCHLORIDE in 0.9% sodium chlorideBaxter Healthcare CorporationANDACurrent
43066-557DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDEDEXMEDETOMIDINE HYDROCHLORIDE in 0.9% sodium chlorideBaxter Healthcare CorporationANDACurrent
43066-561DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDEBaxter Healthcare CorporationANDACurrent
43066-561DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDEBaxter Healthcare CorporationANDACurrent
43066-561DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDEBaxter Healthcare CorporationANDACurrent
43066-561DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDEBaxter Healthcare CorporationANDACurrent
43066-565DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDEBaxter Healthcare CorporationANDACurrent
43066-565DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDEBaxter Healthcare CorporationANDACurrent
43066-565DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDEBaxter Healthcare CorporationANDACurrent
43066-565DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDEBaxter Healthcare CorporationANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
55404ORIG2018-09-07