FDA.reportPublic FDA data

Application 091528

Type
ANDA
Sponsor
NOVEL LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATEHOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATETABLET;ORAL1.5MG;5MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
40032-118Hydrocodone Bitartrate and Homatropine MethylbromideHydrocodone Bitartrate and Homatropine MethylbromideNovel Laboratories, Inc.ANDACurrent
43386-118Hydrocodone Bitartrate and Homatropine MethylbromideHydrocodone Bitartrate and Homatropine MethylbromideLupin Pharmaceuticals,Inc.ANDACurrent
66336-871Hydrocodone Bitartrate and Homatropine MethylbromideHydrocodone Bitartrate and Homatropine MethylbromideDispensing Solutions, Inc.ANDACurrent