FDA.reportPublic FDA data

Application 075440

Type
ANDA
Sponsor
MYLAN LABS LTD

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
67457-381Haloperidol DecanoateHaloperidol DecanoateMylan Institutional LLCANDACurrent
67457-381Haloperidol DecanoateHaloperidol DecanoateMylan Institutional LLCANDACurrent
67457-381Haloperidol DecanoateHaloperidol DecanoateMylan Institutional LLCANDACurrent
67457-381Haloperidol DecanoateHaloperidol DecanoateMylan Institutional LLCANDACurrent
67457-409Haloperidol DecanoateHaloperidol DecanoateMylan Institutional LLCANDACurrent
67457-409Haloperidol DecanoateHaloperidol DecanoateMylan Institutional LLCANDACurrent
67457-409Haloperidol DecanoateHaloperidol DecanoateMylan Institutional LLCANDACurrent
67457-409Haloperidol DecanoateHaloperidol DecanoateMylan Institutional LLCANDACurrent
67457-410Haloperidol DecanoateHaloperidol DecanoateMylan Institutional LLCANDACurrent
67457-410Haloperidol DecanoateHaloperidol DecanoateMylan Institutional LLCANDACurrent
67457-410Haloperidol DecanoateHaloperidol DecanoateMylan Institutional LLCANDACurrent
67457-410Haloperidol DecanoateHaloperidol DecanoateMylan Institutional LLCANDACurrent
70518-1809Haloperidol DecanoateHaloperidol DecanoateREMEDYREPACK INC.ANDACurrent
70518-1809Haloperidol DecanoateHaloperidol DecanoateREMEDYREPACK INC.ANDACurrent
70518-1809Haloperidol DecanoateHaloperidol DecanoateREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8672SUPPL2008-01-09
22473ORIG2007-07-09
8671ORIG2000-02-28