FDA.reportPublic FDA data

Application 212774

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MIDODRINE HYDROCHLORIDEMIDODRINE HYDROCHLORIDETABLET;ORAL2.5MGNoNo
002MIDODRINE HYDROCHLORIDEMIDODRINE HYDROCHLORIDETABLET;ORAL5MGNoNo
003MIDODRINE HYDROCHLORIDEMIDODRINE HYDROCHLORIDETABLET;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-8382Midodrine HydrochlorideMidodrine HydrochlorideNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8382Midodrine HydrochlorideMidodrine HydrochlorideNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8383Midodrine HydrochlorideMidodrine HydrochlorideNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8383Midodrine HydrochlorideMidodrine HydrochlorideNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8384Midodrine HydrochlorideMidodrine HydrochlorideNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8384Midodrine HydrochlorideMidodrine HydrochlorideNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
59651-246Midodrine HydrochlorideMidodrine HydrochlorideAurobindo Pharma LimitedANDACurrent
59651-246Midodrine HydrochlorideMidodrine HydrochlorideAurobindo Pharma LimitedANDACurrent
59651-247Midodrine HydrochlorideMidodrine HydrochlorideAurobindo Pharma LimitedANDACurrent
59651-247Midodrine HydrochlorideMidodrine HydrochlorideAurobindo Pharma LimitedANDACurrent
59651-248Midodrine HydrochlorideMidodrine HydrochlorideAurobindo Pharma LimitedANDACurrent
59651-248Midodrine HydrochlorideMidodrine HydrochlorideAurobindo Pharma LimitedANDACurrent