FDA.reportPublic FDA data

Application 075393

Type
ANDA
Sponsor
TEVA PHARMS USA

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
0703-7011Haloperidol DecanoateHaloperidol DecanoateTeva Parenteral Medicines, Inc.ANDACurrent
0703-7011Haloperidol DecanoateHaloperidol DecanoateTeva Parenteral Medicines, Inc.ANDACurrent
0703-7011Haloperidol DecanoateHaloperidol DecanoateTeva Parenteral Medicines, Inc.ANDACurrent
0703-7011Haloperidol DecanoateHaloperidol DecanoateTeva Parenteral Medicines, Inc.ANDACurrent
0703-7011Haloperidol DecanoateHaloperidol DecanoateTeva Parenteral Medicines, Inc.ANDACurrent
0703-7013Haloperidol DecanoateHaloperidol DecanoateTeva Parenteral Medicines, Inc.ANDACurrent
0703-7013Haloperidol DecanoateHaloperidol DecanoateTeva Parenteral Medicines, Inc.ANDACurrent
0703-7013Haloperidol DecanoateHaloperidol DecanoateTeva Parenteral Medicines, Inc.ANDACurrent
0703-7013Haloperidol DecanoateHaloperidol DecanoateTeva Parenteral Medicines, Inc.ANDACurrent
0703-7013Haloperidol DecanoateHaloperidol DecanoateTeva Parenteral Medicines, Inc.ANDACurrent
0703-7021Haloperidol DecanoateHaloperidol DecanoateTeva Parenteral Medicines, Inc.ANDACurrent
0703-7021Haloperidol DecanoateHaloperidol DecanoateTeva Parenteral Medicines, Inc.ANDACurrent
0703-7021Haloperidol DecanoateHaloperidol DecanoateTeva Parenteral Medicines, Inc.ANDACurrent
0703-7021Haloperidol DecanoateHaloperidol DecanoateTeva Parenteral Medicines, Inc.ANDACurrent
0703-7021Haloperidol DecanoateHaloperidol DecanoateTeva Parenteral Medicines, Inc.ANDACurrent
0703-7023Haloperidol DecanoateHaloperidol DecanoateTeva Parenteral Medicines, Inc.ANDACurrent
0703-7023Haloperidol DecanoateHaloperidol DecanoateTeva Parenteral Medicines, Inc.ANDACurrent
0703-7023Haloperidol DecanoateHaloperidol DecanoateTeva Parenteral Medicines, Inc.ANDACurrent
0703-7023Haloperidol DecanoateHaloperidol DecanoateTeva Parenteral Medicines, Inc.ANDACurrent
0703-7023Haloperidol DecanoateHaloperidol DecanoateTeva Parenteral Medicines, Inc.ANDACurrent
0703-7121Haloperidol DecanoateHaloperidol DecanoateTeva Parenteral Medicines, Inc.ANDACurrent
0703-7121Haloperidol DecanoateHaloperidol DecanoateTeva Parenteral Medicines, Inc.ANDACurrent
0703-7121Haloperidol DecanoateHaloperidol DecanoateTeva Parenteral Medicines, Inc.ANDACurrent
0703-7123Haloperidol DecanoateHaloperidol DecanoateTeva Parenteral Medicines, Inc.ANDACurrent
0703-7123Haloperidol DecanoateHaloperidol DecanoateTeva Parenteral Medicines, Inc.ANDACurrent
0703-7123Haloperidol DecanoateHaloperidol DecanoateTeva Parenteral Medicines, Inc.ANDACurrent
0703-7131Haloperidol DecanoateHaloperidol DecanoateTeva Parenteral Medicines, Inc.ANDACurrent
0703-7131Haloperidol DecanoateHaloperidol DecanoateTeva Parenteral Medicines, Inc.ANDACurrent
0703-7131Haloperidol DecanoateHaloperidol DecanoateTeva Parenteral Medicines, Inc.ANDACurrent
0703-7133Haloperidol DecanoateHaloperidol DecanoateTeva Parenteral Medicines, Inc.ANDACurrent
0703-7133Haloperidol DecanoateHaloperidol DecanoateTeva Parenteral Medicines, Inc.ANDACurrent
0703-7133Haloperidol DecanoateHaloperidol DecanoateTeva Parenteral Medicines, Inc.ANDACurrent
70518-3097Haloperidol DecanoateHaloperidol DecanoateREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
42990ORIG1999-05-11
8645ORIG1999-05-11