FDA.reportPublic FDA data

Application 211061

Type
ANDA
Sponsor
APPCO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HALOPERIDOLHALOPERIDOLTABLET;ORAL0.5MGNoNo
002HALOPERIDOLHALOPERIDOLTABLET;ORAL1MGNoNo
003HALOPERIDOLHALOPERIDOLTABLET;ORAL2MGNoNo
004HALOPERIDOLHALOPERIDOLTABLET;ORAL5MGNoNo
005HALOPERIDOLHALOPERIDOLTABLET;ORAL10MGNoNo
006HALOPERIDOLHALOPERIDOLTABLET;ORAL20MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-8355HaloperidolHaloperidolNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0832-1510HaloperidolHaloperidolUpsher-Smith Laboratories, LLCANDACurrent
0832-1510HaloperidolHaloperidolUpsher-Smith Laboratories, LLCANDACurrent
0832-1520HaloperidolHaloperidolUpsher-Smith Laboratories, LLCANDACurrent
0832-1520HaloperidolHaloperidolUpsher-Smith Laboratories, LLCANDACurrent
0832-1530HaloperidolHaloperidolUpsher-Smith Laboratories, LLCANDACurrent
0832-1530HaloperidolHaloperidolUpsher-Smith Laboratories, LLCANDACurrent
0832-1540HaloperidolHaloperidolUpsher-Smith Laboratories, LLCANDACurrent
0832-1540HaloperidolHaloperidolUpsher-Smith Laboratories, LLCANDACurrent
0832-1550HaloperidolHaloperidolUpsher-Smith Laboratories, LLCANDACurrent
0832-1550HaloperidolHaloperidolUpsher-Smith Laboratories, LLCANDACurrent
0832-1560HaloperidolHaloperidolUpsher-Smith Laboratories, LLCANDACurrent
0832-1560HaloperidolHaloperidolUpsher-Smith Laboratories, LLCANDACurrent
50090-6017HaloperidolHaloperidolA-S Medication SolutionsANDACurrent
70518-2620HaloperidolHaloperidolREMEDYREPACK INC.ANDACurrent
70518-2620HaloperidolHaloperidolREMEDYREPACK INC.ANDACurrent
70518-2620HaloperidolHaloperidolREMEDYREPACK INC.ANDACurrent
70518-2620HaloperidolHaloperidolREMEDYREPACK INC.ANDACurrent
70518-2893HaloperidolHaloperidolREMEDYREPACK INC.ANDACurrent
70518-2893HaloperidolHaloperidolREMEDYREPACK INC.ANDACurrent