FDA.reportPublic FDA data

Application 211309

Type
ANDA
Sponsor
SAPTALIS PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDESOLUTION;ORAL500MG/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42571-360Metformin Hydrochloride Oral SolutionMetformin HydrochlorideMICRO LABS LIMITEDANDACurrent
42571-360Metformin Hydrochloride Oral SolutionMetformin HydrochlorideMICRO LABS LIMITEDANDACurrent
52817-820Metformin Hydrochloride Oral SolutionMetformin HydrochlorideTRUPHARMA, LLCANDACurrent
52817-821Metformin Hydrochloride Oral SolutionMetformin HydrochlorideTRUPHARMA, LLCANDACurrent
52817-822Metformin Hydrochloride Oral SolutionMetformin HydrochlorideTRUPHARMA, LLCANDACurrent
63629-2501Metformin Hydrochloride Oral SolutionMetformin HydrochlorideBryant Ranch PrepackANDACurrent
63629-2502Metformin Hydrochloride Oral SolutionMetformin HydrochlorideBryant Ranch PrepackANDACurrent