FDA.reportPublic FDA data

Application 213055

Type
ANDA
Sponsor
ZYDUS

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
68382-737Midodrine hydrochlorideMidodrine hydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-738Midodrine hydrochlorideMidodrine hydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-739Midodrine hydrochlorideMidodrine hydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
70771-1595Midodrine hydrochlorideMidodrine hydrochlorideCadila Healthcare LimitedANDACurrent
70771-1596Midodrine hydrochlorideMidodrine hydrochlorideCadila Healthcare LimitedANDACurrent
70771-1597Midodrine hydrochlorideMidodrine hydrochlorideCadila Healthcare LimitedANDACurrent