FDA.reportPublic FDA data

Application 211180

Type
ANDA
Sponsor
ZYDUS PHARMS

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
70710-1461Haloperidol decanoateHaloperidol decanoateZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1461Haloperidol decanoateHaloperidol decanoateZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1461Haloperidol decanoateHaloperidol decanoateZydus Pharmaceuticals USA Inc.ANDACurrent
70710-1461Haloperidol decanoateHaloperidol decanoateZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1462Haloperidol decanoateHaloperidol decanoateZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1462Haloperidol decanoateHaloperidol decanoateZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1462Haloperidol decanoateHaloperidol decanoateZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1462Haloperidol decanoateHaloperidol decanoateZydus Pharmaceuticals USA Inc.ANDACurrent
70710-1463Haloperidol decanoateHaloperidol decanoateZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1463Haloperidol decanoateHaloperidol decanoateZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1463Haloperidol decanoateHaloperidol decanoateZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1463Haloperidol decanoateHaloperidol decanoateZydus Pharmaceuticals USA Inc.ANDACurrent
70710-1464Haloperidol decanoateHaloperidol decanoateZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1464Haloperidol decanoateHaloperidol decanoateZydus Pharmaceuticals USA Inc.ANDACurrent
70710-1464Haloperidol decanoateHaloperidol decanoateZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1464Haloperidol decanoateHaloperidol decanoateZydus Pharmaceuticals (USA) Inc.ANDACurrent
72785-0004Haloperidol decanoateHaloperidol decanoateLiva Pharmaceuticals LimitedANDACurrent
72785-0004Haloperidol decanoateHaloperidol decanoateZydus Lifesciences LimitedANDACurrent
72785-0004Haloperidol decanoateHaloperidol decanoateCadila Healthcare LimitedANDACurrent
72785-0005Haloperidol decanoateHaloperidol decanoateLiva Pharmaceuticals LimitedANDACurrent
72785-0005Haloperidol decanoateHaloperidol decanoateZydus Lifesciences LimitedANDACurrent
72785-0005Haloperidol decanoateHaloperidol decanoateCadila Healthcare LimitedANDACurrent
72785-0006Haloperidol decanoateHaloperidol decanoateLiva Pharmaceuticals LimitedANDACurrent
72785-0006Haloperidol decanoateHaloperidol decanoateZydus Lifesciences LimitedANDACurrent
72785-0006Haloperidol decanoateHaloperidol decanoateCadila Healthcare LimitedANDACurrent
72785-0007Haloperidol decanoateHaloperidol decanoateLiva Pharmaceuticals LimitedANDACurrent
72785-0007Haloperidol decanoateHaloperidol decanoateZydus Lifesciences LimitedANDACurrent
72785-0007Haloperidol decanoateHaloperidol decanoateCadila Healthcare LimitedANDACurrent