Application 209882

Type
ANDA
Sponsor
LAURUS LABS LTD

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
42385-902Metformin HydrochlorideMetformin HydrochlorideLaurus Labs LimitedANDACurrent
42385-903Metformin HydrochlorideMetformin HydrochlorideLaurus Labs LimitedANDACurrent
42385-904Metformin HydrochlorideMetformin HydrochlorideLaurus Labs LimitedANDACurrent
42385-947Metformin HydrochlorideMetformin HydrochlorideLaurus Labs LimitedANDACurrent
42385-947Metformin HydrochlorideMetformin HydrochlorideLaurus Labs LimitedANDACurrent
42385-947Metformin HydrochlorideMetformin HydrochlorideLaurus Labs LimitedANDACurrent
42385-948Metformin HydrochlorideMetformin HydrochlorideLaurus Labs LimitedANDACurrent
42385-948Metformin HydrochlorideMetformin HydrochlorideLaurus Labs LimitedANDACurrent
42385-948Metformin HydrochlorideMetformin HydrochlorideLaurus Labs LimitedANDACurrent
42385-949Metformin HydrochlorideMetformin HydrochlorideLaurus Labs LimitedANDACurrent
42385-949Metformin HydrochlorideMetformin HydrochlorideLaurus Labs LimitedANDACurrent
42385-949Metformin HydrochlorideMetformin HydrochlorideLaurus Labs LimitedANDACurrent
68071-2316Metformin HydrochlorideMetformin HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2316Metformin HydrochlorideMetformin HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7867Metformin HydrochlorideMetformin HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-7867Metformin HydrochlorideMetformin HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-7889Metformin HydrochlorideMetformin HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-7889Metformin HydrochlorideMetformin HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
71335-1821Metformin HydrochlorideMetformin HydrochlorideBryant Ranch PrepackANDACurrent