FDA.reportPublic FDA data

Application 212543

Type
ANDA
Sponsor
RUBICON

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
52817-323Midodrine HydrochlorideMidodrine HydrochlorideTruPharma, LLCANDACurrent
52817-323Midodrine HydrochlorideMidodrine HydrochlorideTruPharma, LLCANDACurrent
52817-324Midodrine HydrochlorideMidodrine HydrochlorideTruPharma, LLCANDACurrent
52817-324Midodrine HydrochlorideMidodrine HydrochlorideTruPharma, LLCANDACurrent
52817-325Midodrine HydrochlorideMidodrine HydrochlorideTruPharma, LLCANDACurrent
52817-325Midodrine HydrochlorideMidodrine HydrochlorideTruPharma, LLCANDACurrent
71335-2174Midodrine HydrochlorideMidodrine HydrochlorideBryant Ranch PrepackANDACurrent
72888-112Midodrine HydrochlorideMidodrine HydrochlorideAdvagen Pharma LimitedANDACurrent
72888-113Midodrine HydrochlorideMidodrine HydrochlorideAdvagen Pharma LimitedANDACurrent
72888-114Midodrine HydrochlorideMidodrine HydrochlorideAdvagen Pharma LimitedANDACurrent