FDA.reportPublic FDA data

Application 077361

Type
ANDA
Sponsor
ELITE LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRIMIPRAMINE MALEATETRIMIPRAMINE MALEATECAPSULE;ORALEQ 25MG BASENoNo
002TRIMIPRAMINE MALEATETRIMIPRAMINE MALEATECAPSULE;ORALEQ 50MG BASENoNo
003TRIMIPRAMINE MALEATETRIMIPRAMINE MALEATECAPSULE;ORALEQ 100MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42806-802Trimipramine MaleateTrimipramine MaleateEpic Pharma, LLCANDACurrent
42806-803Trimipramine MaleateTrimipramine MaleateEpic Pharma, LLCANDACurrent
42806-804Trimipramine MaleateTrimipramine MaleateEpic Pharma, LLCANDACurrent
64850-850Trimipramine MaleateTrimipramine MaleateElite Laboratories, Inc.ANDACurrent
64850-851Trimipramine MaleateTrimipramine MaleateElite Laboratories, Inc.ANDACurrent
64850-852Trimipramine MaleateTrimipramine MaleateElite Laboratories, Inc.ANDACurrent
68462-804Trimipramine MaleateTrimipramine MaleateGlenmark Pharmaceuticals Inc.,USAANDACurrent
68462-804Trimipramine MaleateTrimipramine MaleateGlenmark Pharmaceuticals Inc.,USAANDACurrent
68462-805Trimipramine MaleateTrimipramine MaleateGlenmark Pharmaceuticals Inc.,USAANDACurrent
68462-805Trimipramine MaleateTrimipramine MaleateGlenmark Pharmaceuticals Inc.,USAANDACurrent
68462-806Trimipramine MaleateTrimipramine MaleateGlenmark Pharmaceuticals Inc.,USAANDACurrent
68462-806Trimipramine MaleateTrimipramine MaleateGlenmark Pharmaceuticals Inc.,USAANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31229ORIG2006-08-07