FDA.reportPublic FDA data

Application 090888

Type
ANDA
Sponsor
MARKSANS 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
25000-131Metformin HydrochlorideMetformin HydrochlorideMARKSANS PHARMA LIMITEDANDACurrent
25000-131Metformin HydrochlorideMetformin HydrochlorideMARKSANS PHARMA LIMITEDANDACurrent
25000-132Metformin HydrochlorideMetformin HydrochlorideMARKSANS PHARMA LIMITEDANDACurrent
25000-132Metformin HydrochlorideMetformin HydrochlorideMARKSANS PHARMA LIMITEDANDACurrent
25000-134Metformin HydrochlorideMetformin HydrochlorideMARKSANS PHARMA LIMITEDANDACurrent
25000-134Metformin HydrochlorideMetformin HydrochlorideMARKSANS PHARMA LIMITEDANDACurrent
43547-320Metformin HydrochlorideMetformin HydrochlorideSolco healthcare U.S., LLCANDACurrent
43547-321Metformin HydrochlorideMetformin HydrochlorideSolco healthcare U.S., LLCANDACurrent
43547-322Metformin HydrochlorideMetformin HydrochlorideSolco healthcare U.S., LLCANDACurrent
49483-620METFORMIN HCLMETFORMIN HCLTIME CAP LABORATORIES, INCANDACurrent
49483-620METFORMIN HCLMETFORMIN HCLTIME CAP LABORATORIES, INCANDACurrent
49483-621METFORMIN HCLMETFORMIN HCLTIME CAP LABORATORIES, INCANDACurrent
49483-621METFORMIN HCLMETFORMIN HCLTIME CAP LABORATORIES, INCANDACurrent
49483-622METFORMIN HCLMETFORMIN HCLTIME CAP LABORATORIES, INCANDACurrent
49483-622METFORMIN HCLMETFORMIN HCLTIME CAP LABORATORIES, INCANDACurrent