Application 080767

Type
ANDA
Sponsor
IMPAX LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002METHYLTESTOSTERONEMETHYLTESTOSTERONETABLET;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0115-7037METHITESTMETHYLTESTOSTERONEImpax GenericsANDACurrent
0115-7037METHITESTMETHYLTESTOSTERONEAmneal Pharmaceuticals of New York LLCANDACurrent
0115-7037METHITESTMETHYLTESTOSTERONEAmneal Pharmaceuticals of New York LLCANDACurrent