FDA.reportPublic FDA data

Application 076957

Type
ANDA
Sponsor
UNIQUE PHARM LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLUCONAZOLEFLUCONAZOLETABLET;ORAL50MGNoNo
002FLUCONAZOLEFLUCONAZOLETABLET;ORAL100MGNoNo
003FLUCONAZOLEFLUCONAZOLETABLET;ORAL200MGNoNo
004FLUCONAZOLEFLUCONAZOLETABLET;ORAL150MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16571-210FluconazoleFluconazoleRising Pharmaceuticals, Inc.ANDACurrent
16571-211FluconazoleFluconazoleRising Pharmaceuticals, Inc.ANDACurrent
16571-212FluconazoleFluconazoleRising Pharmaceuticals, Inc.ANDACurrent
16571-213FluconazoleFluconazoleRising Pharmaceuticals, Inc.ANDACurrent
70985-013FluconazoleFluconazoleDrug Ocean LLCANDACurrent
70985-013FluconazoleFluconazoleDrug Ocean LLCANDACurrent
70985-013FluconazoleFluconazoleDrug Ocean LLCANDACurrent
70985-013FluconazoleFluconazoleDrug Ocean LLCANDACurrent
70985-013FluconazoleFluconazoleDrug Ocean LLCANDACurrent
70985-014FluconazoleFluconazoleDrug Ocean LLCANDACurrent
70985-014FluconazoleFluconazoleDrug Ocean LLCANDACurrent
70985-014FluconazoleFluconazoleDrug Ocean LLCANDACurrent
70985-014FluconazoleFluconazoleDrug Ocean LLCANDACurrent
70985-014FluconazoleFluconazoleDrug Ocean LLCANDACurrent
70985-015FluconazoleFluconazoleDrug Ocean LLCANDACurrent
70985-015FluconazoleFluconazoleDrug Ocean LLCANDACurrent
70985-015FluconazoleFluconazoleDrug Ocean LLCANDACurrent
70985-015FluconazoleFluconazoleDrug Ocean LLCANDACurrent
70985-015FluconazoleFluconazoleDrug Ocean LLCANDACurrent
70985-016FluconazoleFluconazoleDrug Ocean LLCANDACurrent
70985-016FluconazoleFluconazoleDrug Ocean LLCANDACurrent
70985-016FluconazoleFluconazoleDrug Ocean LLCANDACurrent
70985-016FluconazoleFluconazoleDrug Ocean LLCANDACurrent
70985-016FluconazoleFluconazoleDrug Ocean LLCANDACurrent