FDA.reportPublic FDA data

Application 079019

Type
ANDA
Sponsor
GLENMARK PHARMS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDECAPSULE;ORAL10MGNoNo
002ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDECAPSULE;ORAL18MGNoNo
003ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDECAPSULE;ORAL25MGNoNo
004ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDECAPSULE;ORAL40MGNoNo
005ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDECAPSULE;ORAL60MGNoNo
006ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDECAPSULE;ORAL80MGNoNo
007ATOMOXETINE HYDROCHLORIDEATOMOXETINE HYDROCHLORIDECAPSULE;ORAL100MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16714-755atomoxetineatomoxetineNorthstar Rx LLCANDACurrent
16714-755atomoxetineatomoxetineNorthstar Rx LLCANDACurrent
16714-755atomoxetineatomoxetineNorthstar Rx LLCANDACurrent
16714-755atomoxetineatomoxetineNorthstar Rx LLCANDACurrent
16714-756atomoxetineatomoxetineNorthstar Rx LLCANDACurrent
16714-756atomoxetineatomoxetineNorthstar Rx LLCANDACurrent
16714-756atomoxetineatomoxetineNorthstar Rx LLCANDACurrent
16714-756atomoxetineatomoxetineNorthstar Rx LLCANDACurrent
16714-757atomoxetineatomoxetineNorthstar Rx LLCANDACurrent
16714-757atomoxetineatomoxetineNorthstar Rx LLCANDACurrent
16714-757atomoxetineatomoxetineNorthstar Rx LLCANDACurrent
16714-757atomoxetineatomoxetineNorthstar Rx LLCANDACurrent
16714-758atomoxetineatomoxetineNorthstar Rx LLCANDACurrent
16714-758atomoxetineatomoxetineNorthstar Rx LLCANDACurrent
16714-758atomoxetineatomoxetineNorthstar Rx LLCANDACurrent
16714-758atomoxetineatomoxetineNorthstar Rx LLCANDACurrent
16714-759atomoxetineatomoxetineNorthstar Rx LLCANDACurrent
16714-759atomoxetineatomoxetineNorthstar Rx LLCANDACurrent
16714-759atomoxetineatomoxetineNorthstar Rx LLCANDACurrent
16714-759atomoxetineatomoxetineNorthstar Rx LLCANDACurrent
16714-760atomoxetineatomoxetineNorthstar Rx LLCANDACurrent
16714-760atomoxetineatomoxetineNorthstar Rx LLCANDACurrent
16714-760atomoxetineatomoxetineNorthstar Rx LLCANDACurrent
16714-760atomoxetineatomoxetineNorthstar Rx LLCANDACurrent
16714-761atomoxetineatomoxetineNorthstar Rx LLCANDACurrent
16714-761atomoxetineatomoxetineNorthstar Rx LLCANDACurrent
16714-761atomoxetineatomoxetineNorthstar Rx LLCANDACurrent
16714-761atomoxetineatomoxetineNorthstar Rx LLCANDACurrent
68462-265atomoxetineatomoxetineGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-265atomoxetineatomoxetineGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-265atomoxetineatomoxetineGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-265atomoxetineatomoxetineGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-265atomoxetineatomoxetineGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-266atomoxetineatomoxetineGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-266atomoxetineatomoxetineGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-266atomoxetineatomoxetineGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-266atomoxetineatomoxetineGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-266atomoxetineatomoxetineGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-267atomoxetineatomoxetineGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-267atomoxetineatomoxetineGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-267atomoxetineatomoxetineGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-267atomoxetineatomoxetineGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-267atomoxetineatomoxetineGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-268atomoxetineatomoxetineGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-268atomoxetineatomoxetineGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-268atomoxetineatomoxetineGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-268atomoxetineatomoxetineGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-268atomoxetineatomoxetineGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-269atomoxetineatomoxetineGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-269atomoxetineatomoxetineGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-269atomoxetineatomoxetineGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-269atomoxetineatomoxetineGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-269atomoxetineatomoxetineGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-270atomoxetineatomoxetineGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-270atomoxetineatomoxetineGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-270atomoxetineatomoxetineGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-270atomoxetineatomoxetineGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-270atomoxetineatomoxetineGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-271atomoxetineatomoxetineGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-271atomoxetineatomoxetineGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-271atomoxetineatomoxetineGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-271atomoxetineatomoxetineGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-271atomoxetineatomoxetineGlenmark Pharmaceuticals Inc., USAANDACurrent
70518-2474atomoxetineatomoxetineREMEDYREPACK INC.ANDACurrent
70518-2474atomoxetineatomoxetineREMEDYREPACK INC.ANDACurrent
70518-2474atomoxetineatomoxetineREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
48631ORIG2017-06-02