FDA.reportPublic FDA data

Application 091184

Type
ANDA
Sponsor
ALKEM

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
0440-5739Metformin HydrochlorideMetformin HydrochlorideLiberty Pharmaceuticals, Inc.ANDACurrent
0440-5745Metformin HydrochlorideMetformin HydrochlorideLiberty Pharmaceuticals, Inc.ANDACurrent
0440-5746Metformin HydrochlorideMetformin HydrochlorideLiberty Pharmaceuticals, Inc.ANDACurrent
0904-6326Metformin HydrochlorideMetformin HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6327Metformin HydrochlorideMetformin HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6328Metformin HydrochlorideMetformin HydrochlorideMajor PharmaceuticalsANDACurrent
12634-756Metformin HydrochlorideMetformin HydrochlorideApotheca Inc.ANDACurrent
12634-757Metformin HydrochlorideMetformin HydrochlorideApotheca Inc.ANDACurrent
12634-789Metformin HydrochlorideMetformin HydrochlorideApotheca Inc.ANDACurrent
42708-117Metformin HydrochlorideMetformin HydrochlorideQPharma IncANDACurrent
42708-117Metformin HydrochlorideMetformin HydrochlorideQPharma IncANDACurrent
43353-128Metformin HydrochlorideMetformin HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
50090-2410Metformin HydrochlorideMetformin HydrochlorideA-S Medication SolutionsANDACurrent
50090-2612Metformin HydrochlorideMetformin HydrochlorideA-S Medication SolutionsANDACurrent
50090-2635Metformin HydrochlorideMetformin HydrochlorideA-S Medication SolutionsANDACurrent
50090-3088Metformin HydrochlorideMetformin HydrochlorideA-S Medication SolutionsANDACurrent
53808-1033Metformin HydrochlorideMetformin HydrochlorideState of Florida DOH Central PharmacyANDACurrent
55154-5888Metformin HydrochlorideMetformin HydrochlorideCardinal HealthANDACurrent
55154-5888Metformin HydrochlorideMetformin HydrochlorideCardinal HealthANDACurrent
55700-475Metformin HydrochlorideMetformin HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
67877-217Metformin HydrochlorideMetformin HydrochlorideAscend Laboratories, LLCANDACurrent
67877-217Metformin HydrochlorideMetformin HydrochlorideAscend Laboratories, LLCANDACurrent
67877-217Metformin HydrochlorideMetformin HydrochlorideAscend Laboratories, LLCANDACurrent
67877-218Metformin HydrochlorideMetformin HydrochlorideAscend Laboratories, LLCANDACurrent
67877-218Metformin HydrochlorideMetformin HydrochlorideAscend Laboratories, LLCANDACurrent
67877-218Metformin HydrochlorideMetformin HydrochlorideAscend Laboratories, LLCANDACurrent
67877-221Metformin HydrochlorideMetformin HydrochlorideAscend Laboratories, LLCANDACurrent
67877-221Metformin HydrochlorideMetformin HydrochlorideAscend Laboratories, LLCANDACurrent
67877-221Metformin HydrochlorideMetformin HydrochlorideAscend Laboratories, LLCANDACurrent
68788-6982Metformin HydrochlorideMetformin HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-6982Metformin HydrochlorideMetformin HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-6982Metformin HydrochlorideMetformin HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-7069Metformin HydrochlorideMetformin HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-7069Metformin HydrochlorideMetformin HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-7069Metformin HydrochlorideMetformin HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
70518-0672Metformin HydrochlorideMetformin HydrochlorideREMEDYREPACK INC.ANDACurrent
70882-125Metformin HydrochlorideMetformin HydrochlorideCambridge Therapeutics Technologies, LLCANDACurrent