FDA.reportPublic FDA data

Application 076868

Type
ANDA
Sponsor
ELITE LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LOXAPINE SUCCINATELOXAPINE SUCCINATECAPSULE;ORALEQ 5MG BASENoNo
002LOXAPINE SUCCINATELOXAPINE SUCCINATECAPSULE;ORALEQ 10MG BASENoNo
003LOXAPINE SUCCINATELOXAPINE SUCCINATECAPSULE;ORALEQ 25MG BASENoNo
004LOXAPINE SUCCINATELOXAPINE SUCCINATECAPSULE;ORALEQ 50MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
35573-436LoxapineLoxapineBurel Pharmaceuticals, Inc.ANDACurrent
35573-436LoxapineLoxapineBurel Pharmaceuticals, LLCANDACurrent
35573-437LoxapineLoxapineBurel Pharmaceuticals, Inc.ANDACurrent
35573-437LoxapineLoxapineBurel Pharmaceuticals, LLCANDACurrent
35573-438LoxapineLoxapineBurel Pharmaceuticals, Inc.ANDACurrent
35573-438LoxapineLoxapineBurel Pharmaceuticals, LLCANDACurrent
35573-439LoxapineLoxapineBurel Pharmaceuticals, Inc.ANDACurrent
35573-439LoxapineLoxapineBurel Pharmaceuticals, LLCANDACurrent
64850-890LoxapineLoxapineElite Laboratories, Inc.ANDACurrent
64850-890LoxapineLoxapineElite Laboratories, Inc.ANDACurrent
64850-891LoxapineLoxapineElite Laboratories, Inc.ANDACurrent
64850-891LoxapineLoxapineElite Laboratories, Inc.ANDACurrent
64850-892LoxapineLoxapineElite Laboratories, Inc.ANDACurrent
64850-892LoxapineLoxapineElite Laboratories, Inc.ANDACurrent
64850-893LoxapineLoxapineElite Laboratories, Inc.ANDACurrent
64850-893LoxapineLoxapineElite Laboratories, Inc.ANDACurrent