FDA.reportPublic FDA data

Application 074584

Type
ANDA
Sponsor
UPSHER SMITH LABS

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0832-1024BaclofenBaclofenUpsher-Smith Laboratories, LLCANDACurrent
0832-1024BaclofenBaclofenUpsher-Smith Laboratories, LLCANDACurrent
0832-1025BaclofenBaclofenUpsher-Smith Laboratories, LLCANDACurrent
0832-1025BaclofenBaclofenUpsher-Smith Laboratories, LLCANDACurrent
0832-1054BaclofenBaclofenUpsher-Smith Laboratories, LLCANDACurrent
0832-1054BaclofenBaclofenUpsher-Smith Laboratories, LLCANDACurrent
0832-1054BaclofenBaclofenUpsher-Smith Laboratories, LLCANDACurrent
0832-1055BaclofenBaclofenUpsher-Smith Laboratories, LLCANDACurrent
0832-1055BaclofenBaclofenUpsher-Smith Laboratories, LLCANDACurrent
0832-1055BaclofenBaclofenUpsher-Smith Laboratories, LLCANDACurrent
17856-1024BaclofenBaclofenAtlantic Biologicals CorpsANDACurrent
35356-736BaclofenBaclofenLake Erie Medical & Surgical Supply DBA Quality Care Products LLCANDACurrent
49999-607BaclofenBaclofenLake Erie Medical DBA Quality Care Products LLCANDACurrent