FDA.reportPublic FDA data

Application 214734

Type
ANDA
Sponsor
ALEMBIC PHARMS 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
0615-8443MIDODRINE HYDROCHLORIDEMIDODRINE HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8444MIDODRINE HYDROCHLORIDEMIDODRINE HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8445MIDODRINE HYDROCHLORIDEMIDODRINE HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
46708-338MIDODRINE HYDROCHLORIDEMIDODRINE HYDROCHLORIDEAlembic Pharmaceuticals LimitedANDACurrent
46708-339MIDODRINE HYDROCHLORIDEMIDODRINE HYDROCHLORIDEAlembic Pharmaceuticals LimitedANDACurrent
46708-340MIDODRINE HYDROCHLORIDEMIDODRINE HYDROCHLORIDEAlembic Pharmaceuticals LimitedANDACurrent
62332-338MIDODRINE HYDROCHLORIDEMIDODRINE HYDROCHLORIDEAlembic Pharmaceuticals Inc.ANDACurrent
62332-338MIDODRINE HYDROCHLORIDEMIDODRINE HYDROCHLORIDEAlembic Pharmaceuticals Inc.ANDACurrent
62332-339MIDODRINE HYDROCHLORIDEMIDODRINE HYDROCHLORIDEAlembic Pharmaceuticals Inc.ANDACurrent
62332-339MIDODRINE HYDROCHLORIDEMIDODRINE HYDROCHLORIDEAlembic Pharmaceuticals Inc.ANDACurrent
62332-340MIDODRINE HYDROCHLORIDEMIDODRINE HYDROCHLORIDEAlembic Pharmaceuticals Inc.ANDACurrent
62332-340MIDODRINE HYDROCHLORIDEMIDODRINE HYDROCHLORIDEAlembic Pharmaceuticals Inc.ANDACurrent