FDA.reportPublic FDA data

Application 040103

Type
ANDA
Sponsor
UPSHER SMITH LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BENZTROPINE MESYLATEBENZTROPINE MESYLATETABLET;ORAL0.5MGNoNo
002BENZTROPINE MESYLATEBENZTROPINE MESYLATETABLET;ORAL1MGNoNo
003BENZTROPINE MESYLATEBENZTROPINE MESYLATETABLET;ORAL2MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-7675Benztropine MesylateBenztropine MesylateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7676Benztropine Mesylatebenztropine mesylateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7677Benztropine Mesylatebenztropine mesylateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0832-1080Benztropine Mesylatebenztropine mesylateUpsher-Smith Laboratories, LLCANDACurrent
0832-1081Benztropine Mesylatebenztropine mesylateUpsher-Smith Laboratories, LLCANDACurrent
0832-1082Benztropine Mesylatebenztropine mesylateUpsher-Smith Laboratories, LLCANDACurrent
53808-0826Benztropine Mesylatebenztropine mesylateState of Florida DOH Central PharmacyANDACurrent
53808-0904benztropine mesylateBENZTROPINE MESYLATEState of Florida DOH Central PharmacyANDACurrent
67046-042benztropine mesylatebenztropine mesylateContract Pharmacy Services-PAANDACurrent
67046-043benztropine mesylatebenztropine mesylateContract Pharmacy Services-PAANDACurrent