Application 209101

Type
ANDA
Sponsor
SOMERSET THERAPS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HALOPERIDOL DECANOATEHALOPERIDOL DECANOATEINJECTABLE;INJECTIONEQ 50MG BASE/MLNoNo
002HALOPERIDOL DECANOATEHALOPERIDOL DECANOATEINJECTABLE;INJECTIONEQ 100MG BASE/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70069-030HALOPERIDOL DECANOATEHALOPERIDOL DECANOATESomerset Therapeutics, LLCANDACurrent
70069-030HALOPERIDOL DECANOATEHALOPERIDOL DECANOATESomerset Therapeutics, LLCANDACurrent
70069-030HALOPERIDOL DECANOATEHALOPERIDOL DECANOATESomerset Therapeutics, LLCANDACurrent
70069-030HALOPERIDOL DECANOATEHALOPERIDOL DECANOATESomerset Therapeutics, LLCANDACurrent
70069-030HALOPERIDOL DECANOATEHALOPERIDOL DECANOATESomerset Therapeutics, LLCANDACurrent
70069-030HALOPERIDOL DECANOATEHALOPERIDOL DECANOATESomerset Therapeutics, LLANDACurrent
70069-030HALOPERIDOL DECANOATEHALOPERIDOL DECANOATESomerset Therapeutics, LLCANDACurrent
70069-031HALOPERIDOL DECANOATEHALOPERIDOL DECANOATESomerset Therapeutics, LLCANDACurrent
70069-031HALOPERIDOL DECANOATEHALOPERIDOL DECANOATESomerset Therapeutics, LLCANDACurrent
70069-031HALOPERIDOL DECANOATEHALOPERIDOL DECANOATESomerset Therapeutics, LLCANDACurrent
70069-031HALOPERIDOL DECANOATEHALOPERIDOL DECANOATESomerset Therapeutics, LLCANDACurrent
70069-031HALOPERIDOL DECANOATEHALOPERIDOL DECANOATESomerset Therapeutics, LLANDACurrent
70069-031HALOPERIDOL DECANOATEHALOPERIDOL DECANOATESomerset Therapeutics, LLCANDACurrent
70069-031HALOPERIDOL DECANOATEHALOPERIDOL DECANOATESomerset Therapeutics, LLCANDACurrent
70069-381HALOPERIDOL DECANOATEHALOPERIDOL DECANOATESomerset Therapeutics, LLCANDACurrent
70069-381HALOPERIDOL DECANOATEHALOPERIDOL DECANOATESomerset Therapeutics, LLCANDACurrent
70069-381HALOPERIDOL DECANOATEHALOPERIDOL DECANOATESomerset Therapeutics, LLCANDACurrent
70069-381HALOPERIDOL DECANOATEHALOPERIDOL DECANOATESomerset Therapeutics, LLCANDACurrent
70069-381HALOPERIDOL DECANOATEHALOPERIDOL DECANOATESomerset Therapeutics, LLCANDACurrent
70069-381HALOPERIDOL DECANOATEHALOPERIDOL DECANOATESomerset Therapeutics, LLCANDACurrent
70069-382HALOPERIDOL DECANOATEHALOPERIDOL DECANOATESomerset Therapeutics, LLCANDACurrent
70069-382HALOPERIDOL DECANOATEHALOPERIDOL DECANOATESomerset Therapeutics, LLCANDACurrent
70069-382HALOPERIDOL DECANOATEHALOPERIDOL DECANOATESomerset Therapeutics, LLCANDACurrent
70069-382HALOPERIDOL DECANOATEHALOPERIDOL DECANOATESomerset Therapeutics, LLCANDACurrent
70069-382HALOPERIDOL DECANOATEHALOPERIDOL DECANOATESomerset Therapeutics, LLCANDACurrent
70069-382HALOPERIDOL DECANOATEHALOPERIDOL DECANOATESomerset Therapeutics, LLCANDACurrent
70069-383HALOPERIDOL DECANOATEHALOPERIDOL DECANOATESomerset Therapeutics, LLCANDACurrent
70069-383HALOPERIDOL DECANOATEHALOPERIDOL DECANOATESomerset Therapeutics, LLCANDACurrent
70069-383HALOPERIDOL DECANOATEHALOPERIDOL DECANOATESomerset Therapeutics, LLCANDACurrent
70069-383HALOPERIDOL DECANOATEHALOPERIDOL DECANOATESomerset Therapeutics, LLCANDACurrent
70069-383HALOPERIDOL DECANOATEHALOPERIDOL DECANOATESomerset Therapeutics, LLCANDACurrent
70069-383HALOPERIDOL DECANOATEHALOPERIDOL DECANOATESomerset Therapeutics, LLCANDACurrent
70069-384HALOPERIDOL DECANOATEHALOPERIDOL DECANOATESomerset Therapeutics, LLCANDACurrent
70069-384HALOPERIDOL DECANOATEHALOPERIDOL DECANOATESomerset Therapeutics, LLCANDACurrent
70069-384HALOPERIDOL DECANOATEHALOPERIDOL DECANOATESomerset Therapeutics, LLCANDACurrent
70069-384HALOPERIDOL DECANOATEHALOPERIDOL DECANOATESomerset Therapeutics, LLCANDACurrent
70069-384HALOPERIDOL DECANOATEHALOPERIDOL DECANOATESomerset Therapeutics, LLCANDACurrent
70069-384HALOPERIDOL DECANOATEHALOPERIDOL DECANOATESomerset Therapeutics, LLCANDACurrent
70518-2520HALOPERIDOL DECANOATEHALOPERIDOL DECANOATEREMEDYREPACK INC.ANDACurrent
70518-2520HALOPERIDOL DECANOATEHALOPERIDOL DECANOATEREMEDYREPACK INC.ANDACurrent
70518-2520HALOPERIDOL DECANOATEHALOPERIDOL DECANOATEREMEDYREPACK INC.ANDACurrent
70518-2520HALOPERIDOL DECANOATEHALOPERIDOL DECANOATEREMEDYREPACK INC.ANDACurrent
70518-3170HALOPERIDOL DECANOATEHALOPERIDOL DECANOATEREMEDYREPACK INC.ANDACurrent
70518-3170HALOPERIDOL DECANOATEHALOPERIDOL DECANOATEREMEDYREPACK INC.ANDACurrent