FDA.reportPublic FDA data

Application 076725

Type
ANDA
Sponsor
UPSHER SMITH LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ORVATENMIDODRINE HYDROCHLORIDETABLET;ORAL2.5MGNoNo
002ORVATENMIDODRINE HYDROCHLORIDETABLET;ORAL5MGNoYes
003ORVATENMIDODRINE HYDROCHLORIDETABLET;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0245-0211Midodrine Hydrochloridemidodrine hydrochlorideUpsher-Smith laboratories, LLCANDACurrent
0245-0211Midodrine Hydrochloridemidodrine hydrochlorideUpsher-Smith laboratories, LLCANDACurrent
0245-0211Midodrine Hydrochloridemidodrine hydrochlorideUpsher-Smith laboratories, LLCANDACurrent
0245-0212Midodrine Hydrochloridemidodrine hydrochlorideUpsher-Smith laboratories, LLCANDACurrent
0245-0212Midodrine Hydrochloridemidodrine hydrochlorideUpsher-Smith laboratories, LLCANDACurrent
0245-0212Midodrine Hydrochloridemidodrine hydrochlorideUpsher-Smith laboratories, LLCANDACurrent
0245-0213Midodrine Hydrochloridemidodrine hydrochlorideUpsher-Smith laboratories, LLCANDACurrent
0245-0213Midodrine Hydrochloridemidodrine hydrochlorideUpsher-Smith laboratories, LLCANDACurrent
0245-0213Midodrine Hydrochloridemidodrine hydrochlorideUpsher-Smith laboratories, LLCANDACurrent
55154-5623Midodrine HClmidodrine hydrochlorideCardinal HealthANDACurrent
55154-5623Midodrine HClmidodrine hydrochlorideCardinal Health 107, LLCANDACurrent
55154-5623Midodrine HClmidodrine hydrochlorideCardinal HealthANDACurrent