FDA.reportPublic FDA data

Application 206145

Type
ANDA
Sponsor
ALKEM LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL500MGNoNo
002METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL750MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-8415Metformin HydrochlorideMetformin HydrochlorideNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
50090-5246Metformin HydrochlorideMetformin HydrochlorideA-S Medication SolutionsANDACurrent
50090-5246Metformin HydrochlorideMetformin HydrochlorideA-S Medication SolutionsANDACurrent
50090-5396Metformin HydrochlorideMetformin HydrochlorideA-S Medication SolutionsANDACurrent
50090-5396Metformin HydrochlorideMetformin HydrochlorideA-S Medication SolutionsANDACurrent
50090-5396Metformin HydrochlorideMetformin HydrochlorideA-S Medication SolutionsANDACurrent
50090-5396Metformin HydrochlorideMetformin HydrochlorideA-S Medication SolutionsANDACurrent
50090-5397Metformin HydrochlorideMetformin HydrochlorideA-S Medication SolutionsANDACurrent
60687-640Metformin HydrochlorideMetformin HydrochlorideAmerican Health PackagingANDACurrent
60687-640Metformin HydrochlorideMetformin HydrochlorideAmerican Health PackagingANDACurrent
67877-413Metformin HydrochlorideMetformin HydrochlorideAscend Laboratories, LLCANDACurrent
67877-413Metformin HydrochlorideMetformin HydrochlorideAscend Laboratories, LLCANDACurrent
67877-413Metformin HydrochlorideMetformin HydrochlorideAscend Laboratories, LLCANDACurrent
67877-414Metformin HydrochlorideMetformin HydrochlorideAscend Laboratories, LLCANDACurrent
67877-414Metformin HydrochlorideMetformin HydrochlorideAscend Laboratories, LLCANDACurrent
67877-414Metformin HydrochlorideMetformin HydrochlorideAscend Laboratories, LLCANDACurrent
68071-2829Metformin HydrochlorideMetformin HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2829Metformin HydrochlorideMetformin HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2829Metformin HydrochlorideMetformin HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
70518-3599Metformin HydrochlorideMetformin HydrochlorideREMEDYREPACK INC.ANDACurrent
70934-788Metformin HydrochlorideMetformin HydrochlorideDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
70934-788Metformin HydrochlorideMetformin HydrochlorideDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
70934-792Metformin HydrochlorideMetformin HydrochlorideDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
71205-686Metformin HydrochlorideMetformin HydrochlorideProficient Rx LPANDACurrent
71205-686Metformin HydrochlorideMetformin HydrochlorideProficient Rx LPANDACurrent
71610-578Metformin HydrochlorideMetformin HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent