FDA.reportPublic FDA data

Application 078401

Type
ANDA
Sponsor
NORTHSTAR HLTHCARE

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16714-072BaclofenBaclofenNorthstar RxLLCANDACurrent
16714-072BaclofenBaclofenNorthstar RxLLCANDACurrent
16714-072BaclofenBaclofenNorthstar RxLLCANDACurrent
63739-480BaclofenBaclofenMcKesson Corporation dba SKY PackagingANDACurrent
63739-480BaclofenBaclofenMckesson Corporation DBA SKY PackaginngANDACurrent
63739-480BaclofenBaclofenMcKesson CorporationANDACurrent
63739-480BaclofenBaclofenMckesson Corporation DBA SKY PackaginngANDACurrent
71610-446BaclofenBaclofenAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-446BaclofenBaclofenAphena Pharma Solutions - Tennessee, LLCANDACurrent
80425-0081BaclofenBaclofen 20mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0081BaclofenBaclofenAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0081BaclofenBaclofenAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0081BaclofenBaclofenAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent