FDA.reportPublic FDA data

Application 206628

Type
NDA
Sponsor
HQ SPCLT PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDESOLUTION;INTRAVENOUSEQ 400MCG BASE/4ML (EQ 100MCG BASE/ML)YesNo
002DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDESOLUTION;INTRAVENOUSEQ 1MG BASE/10ML (EQ 100MCG BASE/ML)YesYes
003DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDESOLUTION;INTRAVENOUSEQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)YesNo
004DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDESOLUTION;INTRAVENOUSEQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)YesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
44567-600Dexmedetomidine HydrochlorideDexmedetomidine HydrochlorideWG Critical Care, LLCNDACurrent
44567-600Dexmedetomidine HydrochlorideDexmedetomidine HydrochlorideWG Critical Care, LLCNDACurrent
44567-600Dexmedetomidine HydrochlorideDexmedetomidine HydrochlorideWG Critical Care, LLCNDACurrent
44567-601Dexmedetomidine HydrochlorideDexmedetomidine HydrochlorideWG Critical Care, LLCNDACurrent
44567-601Dexmedetomidine HydrochlorideDexmedetomidine HydrochlorideWG Critical Care, LLCNDACurrent
44567-601Dexmedetomidine HydrochlorideDexmedetomidine HydrochlorideWG Critical Care, LLCNDACurrent
44567-602Dexmedetomidine HydrochlorideDexmedetomidine HydrochlorideWG Critical Care, LLCNDACurrent
44567-602Dexmedetomidine HydrochlorideDexmedetomidine HydrochlorideWG Critical Care, LLCNDACurrent
44567-602Dexmedetomidine HydrochlorideDexmedetomidine HydrochlorideWG Critical Care, LLCNDACurrent
44567-603Dexmedetomidine HydrochlorideDexmedetomidine HydrochlorideWG Critical Care, LLCNDACurrent
44567-603Dexmedetomidine HydrochlorideDexmedetomidine HydrochlorideWG Critical Care, LLCNDACurrent
44567-603Dexmedetomidine HydrochlorideDexmedetomidine HydrochlorideWG Critical Care, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85835SUPPL 2026-05-05
85823SUPPL 2026-05-04
77928SUPPL 2024-03-25
77915SUPPL 2024-03-22
75286SUPPL 2023-08-25
75269SUPPL 2023-08-23
45380SUPPL2016-09-21
45352SUPPL2016-09-21
43526ORIG2016-05-27
19729ORIG2015-10-26
10589ORIG2015-10-23