FDA.reportPublic FDA data

Application 075978

Type
ANDA
Sponsor
HERITAGE PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDETABLET;ORAL500MGNoNo
002METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDETABLET;ORAL850MGNoNo
003METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDETABLET;ORAL1GMNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-1048Metformin HydrochlorideMetformin HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1049Metformin HydrochlorideMetformin HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7214Metformin HydrochlorideMetformin HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0615-7661Metformin HydrochlorideMetformin HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7662Metformin HydrochlorideMetformin HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7663Metformin HydrochlorideMetformin HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
10544-058Metformin HydrochlorideMetformin HydrochlorideBlenheim Pharmacal, Inc.ANDACurrent
10544-067Metformin HydrochlorideMetformin HydrochlorideBlenheim Pharmacal, Inc.ANDACurrent
10544-068Metformin HydrochlorideMetformin HydrochlorideBlenheim Pharmacal, Inc.ANDACurrent
48433-326Metformin HydrochlorideMetformin HydrochlorideSafecor Health, LLCANDACurrent
63629-6794Metformin HydrochlorideMetformin HydrochlorideBryant Ranch PrepackANDACurrent
66116-370Metformin HydrochlorideMetformin HydrochlorideMedVantx, Inc.ANDACurrent
66116-378Metformin HydrochlorideMetformin HydrochlorideMedVantx, Inc.ANDACurrent
68071-3226Metformin HydrochlorideMetformin HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent