FDA.reportPublic FDA data

Application 076577

Type
ANDA
Sponsor
MYLAN PHARMS INC

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
0378-1901Midodrine Hydrochloridemidodrine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-1901Midodrine Hydrochloridemidodrine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-1901Midodrine Hydrochloridemidodrine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-1901Midodrine Hydrochloridemidodrine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-1901Midodrine Hydrochloridemidodrine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-1902Midodrine Hydrochloridemidodrine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-1902Midodrine Hydrochloridemidodrine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-1902Midodrine Hydrochloridemidodrine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-1902Midodrine Hydrochloridemidodrine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-1902Midodrine Hydrochloridemidodrine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-1903Midodrine Hydrochloridemidodrine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-1903Midodrine Hydrochloridemidodrine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-1903Midodrine Hydrochloridemidodrine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-1903Midodrine Hydrochloridemidodrine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-1903Midodrine Hydrochloridemidodrine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0615-5647Midodrine HydrochlorideMidodrine HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7559Midodrine HydrochlorideMidodrine HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7566Midodrine HydrochlorideMidodrine HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
51079-453Midodrine Hydrochloridemidodrine hydrochlorideMylan Institutional Inc.ANDACurrent
51079-453Midodrine Hydrochloridemidodrine hydrochlorideMylan Institutional Inc.ANDACurrent
51079-453Midodrine Hydrochloridemidodrine hydrochlorideMylan Institutional Inc.ANDACurrent
55154-5696Midodrine HydrochlorideMidodrine HydrochlorideCardinal HealthANDACurrent
55154-5696Midodrine HydrochlorideMidodrine HydrochlorideCardinal HealthANDACurrent
55154-5696Midodrine HydrochlorideMidodrine HydrochlorideCardinal Health 107, LLCANDACurrent
55154-5696Midodrine HydrochlorideMidodrine HydrochlorideCardinal HealthANDACurrent
63629-6928Midodrine Hydrochloridemidodrine hydrochlorideBryant Ranch PrepackANDACurrent
63629-6928Midodrine Hydrochloridemidodrine hydrochlorideBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
43089ORIG2005-07-22