FDA.reportPublic FDA data

Application 077971

Type
ANDA
Sponsor
IMPAX LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BACLOFENBACLOFENTABLET;ORAL10MGNoNo
002BACLOFENBACLOFENTABLET;ORAL20MGNoNo
003BACLOFENBACLOFENTABLET;ORAL5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0115-1010BaclofenBaclofenAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1010BaclofenBaclofenAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1010BaclofenBaclofenAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1010BaclofenBaclofenAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1010BaclofenBaclofenAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1011BaclofenBaclofenAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1011BaclofenBaclofenAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1011BaclofenBaclofenAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1012BaclofenBaclofenAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1012BaclofenBaclofenAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1012BaclofenBaclofenAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1012BaclofenBaclofenAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1012BaclofenBaclofenAmneal Pharmaceuticals of New York LLCANDACurrent
0615-8411BaclofenBaclofenNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8412BaclofenBaclofenNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent