FDA.reportPublic FDA data

Application 207613

Type
ANDA
Sponsor
UNIQUE PHARM LABS

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
64980-433Midodrine HydrochlorideMidodrine HydrochlorideRising Pharmaceuticals, Inc.ANDACurrent
64980-434Midodrine HydrochlorideMidodrine HydrochlorideRising Pharmaceuticals, Inc.ANDACurrent
64980-435Midodrine HydrochlorideMidodrine HydrochlorideRising Pharmaceuticals, Inc.ANDACurrent
70985-005Midodrine HydrochlorideMidodrine HydrochlorideDrug Ocean LLCANDACurrent
70985-005Midodrine HydrochlorideMidodrine HydrochlorideDrug Ocean LLCANDACurrent
70985-006Midodrine HydrochlorideMidodrine HydrochlorideDrug Ocean LLCANDACurrent
70985-006Midodrine HydrochlorideMidodrine HydrochlorideDrug Ocean LLCANDACurrent
70985-007Midodrine HydrochlorideMidodrine HydrochlorideDrug Ocean LLCANDACurrent
70985-007Midodrine HydrochlorideMidodrine HydrochlorideDrug Ocean LLCANDACurrent
71335-1705Midodrine HydrochlorideMidodrine HydrochlorideBryant Ranch PrepackANDACurrent
71335-1705Midodrine HydrochlorideMidodrine HydrochlorideBryant Ranch PrepackANDACurrent