FDA.reportPublic FDA data

Application 211844

Type
NDA
Sponsor
INFORLIFE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MIDAZOLAMMIDAZOLAMUNKNOWNUNKNOWNYesNo
002MIDAZOLAM IN 0.9% SODIUM CHLORIDEMIDAZOLAMSOLUTION;INTRAVENOUS100MG/100ML (1MG/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
44567-610MIDAZOLAM HYDROCHLORIDEMIDAZOLAM HYDROCHLORIDEWG Critical Care, LLC.NDACurrent
44567-610MIDAZOLAM HYDROCHLORIDEMIDAZOLAM HYDROCHLORIDEWG Critical Care, LLC.NDACurrent
44567-610MIDAZOLAM HYDROCHLORIDEMIDAZOLAM HYDROCHLORIDEWG Critical Care, LLC.NDACurrent
44567-610MIDAZOLAM HYDROCHLORIDEMIDAZOLAM HYDROCHLORIDEWG Critical Care, LLC.NDACurrent
44567-610MIDAZOLAM HYDROCHLORIDEMIDAZOLAM HYDROCHLORIDEWG Critical Care, LLC.NDACurrent
44567-611MIDAZOLAM HYDROCHLORIDEMIDAZOLAM HYDROCHLORIDEWG Critical Care, LLC.NDACurrent
44567-611MIDAZOLAM HYDROCHLORIDEMIDAZOLAM HYDROCHLORIDEWG Critical Care, LLC.NDACurrent
44567-611MIDAZOLAM HYDROCHLORIDEMIDAZOLAM HYDROCHLORIDEWG Critical Care, LLC.NDACurrent
44567-611MIDAZOLAM HYDROCHLORIDEMIDAZOLAM HYDROCHLORIDEWG Critical Care, LLC.NDACurrent
44567-611MIDAZOLAM HYDROCHLORIDEMIDAZOLAM HYDROCHLORIDEWG Critical Care, LLC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79143SUPPL 2024-07-22
73217SUPPL2023-01-17
73188SUPPL2023-01-17
69040SUPPL2021-10-20
68046ORIG2021-07-12
66859ORIG2021-03-24
66836ORIG2021-03-23