FDA.reportPublic FDA data

Application 077370

Type
ANDA
Sponsor
PRINSTON INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GLIMEPIRIDEGLIMEPIRIDETABLET;ORAL1MGNoNo
002GLIMEPIRIDEGLIMEPIRIDETABLET;ORAL2MGNoNo
003GLIMEPIRIDEGLIMEPIRIDETABLET;ORAL4MGNoNo
004GLIMEPIRIDEGLIMEPIRIDETABLET;ORAL8MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43547-394GlimepirideglimepirideSolco Healthcare U.S., LLCANDACurrent
43547-394GlimepirideglimepirideSolco Healthcare U.S., LLCANDACurrent
43547-394GlimepirideglimepirideSolco Healthcare U.S., LLCANDACurrent
43547-395GlimepirideglimepirideSolco Healthcare U.S., LLCANDACurrent
43547-395GlimepirideglimepirideSolco Healthcare U.S., LLCANDACurrent
43547-395GlimepirideglimepirideSolco Healthcare U.S., LLCANDACurrent
43547-396GlimepirideglimepirideSolco Healthcare U.S., LLCANDACurrent
43547-396GlimepirideglimepirideSolco Healthcare U.S., LLCANDACurrent
43547-396GlimepirideglimepirideSolco Healthcare U.S., LLCANDACurrent
61919-720GLIMEPIRIDEGLIMEPIRIDEDirectRXANDACurrent