FDA.reportPublic FDA data

Application 075965

Type
ANDA
Sponsor
SANDOZ

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
24658-790Metformin HydrochlorideMetformin HydrochloridePuraCap Laboratories LLC dba Blu PharmaceuticalsANDACurrent
24658-791Metformin HydrochlorideMetformin HydrochloridePuraCap Laboratories LLC dba Blu PharmaceuticalsANDACurrent
24658-792Metformin HydrochlorideMetformin HydrochloridePuraCap Laboratories LLC dba Blu PharmaceuticalsANDACurrent
42806-213Metformin HydrochlorideMetformin HydrochlorideEpic Pharma, LLCANDACurrent
42806-213Metformin HydrochlorideMetformin HydrochlorideEpic Pharma, LLCANDACurrent
42806-213Metformin HydrochlorideMetformin HydrochlorideEpic Pharma, LLCANDACurrent
42806-215Metformin HydrochlorideMetformin HydrochlorideEpic Pharma, LLCANDACurrent
42806-215Metformin HydrochlorideMetformin HydrochlorideEpic Pharma, LLCANDACurrent
42806-215Metformin HydrochlorideMetformin HydrochlorideEpic Pharma, LLCANDACurrent
42806-221Metformin HydrochlorideMetformin HydrochlorideEpic Pharma, LLCANDACurrent
42806-221Metformin HydrochlorideMetformin HydrochlorideEpic Pharma, LLCANDACurrent
42806-221Metformin HydrochlorideMetformin HydrochlorideEpic Pharma, LLCANDACurrent
43353-894metformin hydrochloridemetformin hydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-936metformin hydrochloridemetformin hydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent